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Cognitive & Behavioral Neurology Program Clinical Trials

Alzheimer's Disease Neuroimaging Initiative 2

NCT ID: NCT01231971
Principal Investigator: Ronald Petersen, MD, PhD

The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the neuroscience of AD. This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.

Condition:

The Alzheimer's Disease Neuroimaging Initiative (ADNI) began in October 2004 as a landmark study with a public-private partnership that gathered and analyzed thousands of brain scans, genetic profiles and biomarkers in blood and cerebrospinal fluid (CSF). Although the original goal was to define biomarkers for use in clinical trials to determine the best way to measure treatment effects of Alzheimer's disease (AD), the goal has been expanded to using biomarkers to identify AD at a pre-dementia stage. ADNI1 involves scientists at 59 research centers, 54 in the U.S. and five in Canada. Originally 800 participants were enrolled. This group was comprised of 200 participants with AD, 400 with mild cognitive impairment (MCI) and 200 with normal cognition. In ADNI-GO, an estimated 200 participants with early amnestic MCI (EMCI) were enrolled to understand and characterize the mildest symptomatic phase of AD. An additional 650 participants will be enrolled under ADNI2. Some of the leading-edge technologies under study are brain-imaging techniques, such as positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in the brain); PET using a radioactive compound (Florbetapir F 18) that measures brain beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain's structure and function change as AD starts and progresses. Biomarkers in cerebrospinal fluid are revealing other changes that could identify which patients with MCI will develop Alzheimer's. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid. (Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer's disease.) ADNI2 extends the work of ADNI1 and ADNI GO to understand the progression of AD. The overall goal is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD, as the pathology evolves from normal aging through very mild symptoms, to MCI, to dementia. The overall impact of this study will be increased knowledge concerning the sequence and timing of events leading to MCI and AD, development of better clinical and imaging/fluid biomarker methods for early detection and for monitoring the progression of these conditions, and facilitation of clinical trials to slow disease progression, ultimately contributing to the prevention of AD.

Eligibility:

Inclusion Criteria: Participants will be classified as either normal controls, SMC, EMCI, LMCI or AD participants. General Inclusion Criteria will apply to all groups, with specific criteria for each group as described below: General (applies to each category): - Geriatric Depression Scale less than 6. - Age between *55-90 (inclusive). *For normal controls and SMC participants, age must be between 65-90. - Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol. - Visual and auditory acuity adequate for neuropsychological testing. - Good general health with no diseases expected to interfere with the study. - Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile). - Willing and able to participate in a longitudinal imaging study. - Hachinski less than or equal to 4. - Completed six grades of education or has a good work history (sufficient to exclude mental retardation). - Must speak English or Spanish fluently. - Willing to undergo repeated MRIs (3Tesla) and at least two PET scans (one FDG and one Amyloid imaging) and no medical contraindications to MRI. - Agrees to collection of blood for Genome Wide Association Studies (GWAS), APOE testing and DNA and RNA banking. - Agrees to collection of blood for biomarker testing. - Agrees to at least one lumbar puncture for the collection of CSF. Specific Inclusion Criteria for normal controls: - Participant must be free of memory complaints, verified by a study partner. - Normal memory function score on Wechsler Memory Scale (adjusted for education) - Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive) - Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0 - Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living - Stability of Permitted Medications for 4 weeks. In particular, participants may take: - Antidepressants lacking significant anticholinergic side effects - Estrogen replacement therapy is permissible - Gingko biloba is permissible, but discouraged - Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening Specific Inclusion Criteria for SMC participants: - Subjects that are "self-referrals" that have a significant subjective memory concern - Significant memory concern confirmed by a Cognitive Change Index score of more than or equal to 16 - Normal memory function score on Wechsler Memory Scale (adjusted for education) - Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive) - Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0 - Cognitively normal, based on the absence of significant memory impairment in cognitive function or activities of daily living - Stability of Permitted Medications for 4 weeks. In particular, subjects may take: - Antidepressants lacking significant anticholinergic side effects - Estrogen replacement therapy is permissible - Gingko biloba is permissible, but discouraged - Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening Specific Inclusion Criteria for EMCI and LMCI participants: - Participant must have a subjective memory concern as reported by participant, study partner, or clinician - Abnormal memory function score on Wechsler Memory Scale (adjusted for education) - Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive) - Clinical Dementia Rating (CDR) = 0.5; Memory Box score must be at least 0.5 - General cognition and functional performance sufficiently preserved such that a diagnosis of AD cannot be made by the site physician at the time of the screening visit - Stability of Permitted Medications for 4 weeks. In particular, participants may take: - Antidepressants lacking significant anticholinergic side effects - Estrogen replacement therapy - Gingko biloba is permissible, but discouraged - Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening - Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening Specific Inclusion Criteria for AD participants: - Participant must have a subjective memory concern as reported by participant, study partner, or clinician - Abnormal memory function score on Wechsler Memory Scale (adjusted for education) - Mini-Mental State Exam (MMSE) score between 20 and 26 (inclusive) - Clinical Dementia Rating (CDR) = 0.5 or 1.0 - National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD - Stability of Permitted Medications for 4 weeks. In particular, participants may take: - Antidepressants lacking significant anticholinergic side effects - Estrogen replacement therapy - Gingko biloba is permissible, but discouraged - Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening - Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening Specific Inclusion Criteria for follow-up participants from ADNI1 and ADNI GO: - Must have been enrolled and followed in ADNI1 for at least one year or enrolled in ADNI-GO with original diagnosis of Cognitively Normal (CN), Mild Cognitive Impairment (MCI), or Early Mild Cognitive Impairment (EMCI) regardless of whether a diagnostic conversion has occurred since initial enrollment in ADNI. - Willing and able to continue to participate in an ongoing longitudinal study. A reduced battery of tests is allowable if the participant is not able/willing to complete the full battery. - Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol. Exclusion Criteria: General (applies to each category): - Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions; Participants with multiple lacunes or lacunes in a critical memory structure are excluded - Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body - Major depression, bipolar disorder as described in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) within the past 1 year - Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder - History of schizophrenia - History of alcohol or substance abuse or dependence within the past 2 years - Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol - Clinically significant abnormalities in B12, or TFTs that might interfere with the study - Residence in skilled nursing facility - Current use of specific psychoactive medications (e.g.,certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); Current use of warfarin or dabigatran (exclusionary for lumbar puncture). - Use of investigational agents one month prior to entry and for the duration of the trial - Participation in clinical studies involving neuropsychological measures being collected more than one time per year - Exclusion for FDG PET scan and amyloid imaging with Florbetapir F 18: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1. - Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director Specific Exclusion Criteria for normal controls and SMC participants: - Any significant neurologic disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities Specific Exclusion Criteria for EMCI and LMCI participants: - Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. Specific Exclusion Criteria for AD participants: - Any significant neurologic disease other than Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. Specific Exclusion Criteria for follow-up participants from ADNI1 and ADNI GO: - Participants will not be able to participate in FDG PET scan and amyloid imaging with Florbetapir F 18 if the following is true: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1.

Gender: Both
Minimum Age: 55 Years
Maximum Age: 90 Years
Healthy Volunteers: Accepts Healthy Volunteers

ADNI: Alzheimer's Disease Neuroimaging Initiative

NCT ID: NCT00106899
Principal Investigator: Michael W. Weiner, MD

The purpose of this study is to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). This information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied.

Condition:

This study will test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessment can be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The information obtained by studying changes in the brain images of MCI and AD patients and healthy individuals, as well as other assessment tools, will be used to determine the best methods for measuring treatment effects in patients with MCI and AD. Approximately 800 participants, ranging in age from 55 to 90, will be recruited for the study: 400 patients with MCI, 200 with early AD, and 200 normal controls. Patients with MCI and normal controls will be followed for 3 years, and those with AD will be followed for 2 years. At 6-month intervals, all participants will be seen in person or contacted by telephone. All participants will undergo repeated scanning and blood and urine biomarkers will be collected at the time of each scan. All patients will be asked if they are willing to undergo lumbar puncture at baseline and year one, with the goal of a minimum of 20% and as many as 50% of each group providing CSF (cerebrospinal fluid) samples for analysis and storage for future analyses. NOTE: Beginning in Spring 2007 a subset of the ADNI participants will be offered the opportunity to participate in a supplemental study. The PIB (Pittsburgh Compound B) study provides imaging of amyloid plaque burden. PIB PET scans will be conducted in 24 control, 48 MCI, and 24 AD participants at approximately 16 ADNI PET sites. For entering participants with no previous PET FDG scans, controls and MCI participants will be scanned with PIB at entry (baseline), 12, 24, and 36 months, and AD participants will be scanned with PIB at entry (baseline), 12, and 24 months. For participants who have undergone previous (baseline and 6 month) PET FDG scans, controls and MCI participants will be scanned with PIB at 12, 24, and 36 months, and AD participants will be scanned with PIB at 12 and 24 months.

Eligibility:

Inclusion Criteria: Participants will be classified as either MCI patients, AD patients, or normal controls. General Inclusion Criteria will apply to all groups, with specific criteria for each group as described below: General (applies to each category): - Between 55 and 90 years of age (Currently, ADNI sites are only recruiting volunteers age 70-90 among people with no memory problems) - Study partner or caregiver to accompany patient to all scheduled visits - Fluent in English or Spanish - Permitted medications stable for at least 4 weeks prior to screening - Adequate visual and auditory acuity to allow neuropsychological testing - Good general health with no additional diseases expected to interfere with the study - Women must be two years post-menopausal or surgically sterile - Willing and able to complete all baseline assessments, and to participate in the 2-3 year protocol - Willing to undergo neuroimaging and provide DNA and plasma samples as specified - Completed 6 grades of education or sufficient work history to exclude mental retardation - Modified Hachinski score <=4 - Geriatric Depression Scale <6 Specific Criteria for MCI and AD patients: - Memory complaint by patient or study partner - Abnormal memory function score on Wechsler Memory Scale (adjusted for education) - Mini-Mental State Exam score between 24 and 30 (MCI) or 20 and 26 (AD) - Clinical Dementia Rating = 0.5; Memory Box score at least 0.5 (MCI) or 1.0 (AD) Exclusion Criteria: - Any significant neurologic disease other than Alzheimer's disease - Abnormal baseline MRI - Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body - Major depression, bipolar disorder, history of schizophrenia - History of alcohol or substance abuse or dependency within the past 2 years - Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol - Clinically significant laboratory abnormalities - Residence in skilled nursing facility - Participation in clinical studies involving neuropsychological measures being collected more than one time per year Specific Exclusion Criteria for MCI and AD: - Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol. Prohibited medications: - Specific psychoactive medications (for example, certain antidepressants, anti-anxiety medications, sleeping pills, etc.) - Warfarin (Coumadin) - Investigational agents

Gender: Both
Minimum Age: 55 Years
Maximum Age: 90 Years
Healthy Volunteers: Accepts Healthy Volunteers

Alzheimer's Disease Neuroimaging Initiative Grand Opportunity

NCT ID: NCT01078636
Principal Investigator: Ronald Petersen, MD, PhD

The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI-GO seeks to define and characterize the mildest symptomatic phase of AD, referred to in this study as early amnestic MCI (EMCI). This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.

Condition:

This project continues the work from ADNI1, the goal of which is to test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessments can be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The goal of the study is to determine relationships among the clinical, cognitive, imaging, genetic, and biochemical biomarker characteristics of the stage of the AD spectrum that precedes MCI, the mildest symptomatic phase of AD, referred to here as EMCI. The ADNI-GO model posits that AD begins with amyloid β (Aβ) deposition in the cortex, which leads to synaptic dysfunction, neurodegeneration, and cognitive/ functional decline. Some of the leading-edge technologies under study are brain-imaging techniques, such as positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in the brain); PET using a radioactive compound (F-AV-45) that measures brain beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain's structure and function change as AD starts and progresses. Biomarkers in cerebrospinal fluid are revealing other changes that could identify which patients with MCI will develop Alzheimer's. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid. (Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer's disease.) All participants from ADNI1 who are in the normal and MCI stages will continue to be followed in ADNI-GO. The next step is to scan and analyze the brains of people with EMCI; 200 EMCI participants will be enrolled to narrow the gap between cognitively normal (CN) and "late MCI (LMCI)" participants currently enrolled in ADNI. The overall impact of this study will be increased knowledge concerning the sequence and timing of events leading to MCI and AD, development of better clinical and imaging/fluid biomarker methods for early detection and for monitoring the progression of these conditions, and facilitation of clinical trials of treatments to slow disease progression, ultimately contributing to the prevention of AD.

Eligibility:

EMCI Inclusion Criteria: - Between 55 and 90 years of age - Study partner to accompany patient to all clinic visits for the duration of the protocol - Memory complaint by patient and/or study partner - Abnormal memory function score on Wechsler Memory Scale (adjusted for education) - Mini-Mental State Exam score between 24 and 30 (inclusive) - Clinical Dementia Rating = 0.5; Memory Box score at least 0.5 - General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit - Stability of the following permitted medications for 4 weeks (unless stated otherwise): - Antidepressants lacking significant anticholinergic side effects - Estrogen replacement therapy - Gingko biloba is permissible, but discouraged - Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening - Cholinesterase inhibitors and memantine if stable for 12 weeks prior to screening - Geriatric Depression Scale less than 6 - Visual and auditory acuity adequate for neuropsychological testing - Good general health with no diseases expected to interfere with the study - Not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile) - Hachinski less than or equal to 4 - Six grade education or has a good work history (sufficient to exclude mental retardation) - Fluent in English or Spanish - Agrees to at least one lumbar puncture for the collection of CSF - Willing and able to complete all baseline assessments - Willing to undergo repeated MRIs and at least two PET scans and willing to provide DNA and plasma samples as specified - Willing and able to participate in a longitudinal imaging study Specific Inclusion Criteria for follow-up participants from ADNI1: - Must have been enrolled and followed in ADNI for at least one year diagnosed as either Mild Cognitive Impairment (MCI) or Cognitively Normal (CN) regardless of whether a diagnostic conversion has occurred since enrolling in ADNI - Willing and able to continue to participate in an ongoing longitudinal study; a reduced battery of tests can be requested from the project directors if the participant is not able/willing to complete the full battery - Study partner who has frequent contact with participant and can accompany participant to all clinic visits for the duration of the protocol Exclusion Criteria: - Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities - Screening/baseline MRI scans with evidence of infection, infarction, or other focal lesions; multiple lacunes or lacunes in a critical memory structure - Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body - Major depression, bipolar disorder as described in DSM-IV within the past 1 year - Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol - History of schizophrenia - History of alcohol or substance abuse or dependence within the past 2 years - Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol - Clinically significant abnormalities in B12, or TFTs that might interfere with the study - Residence in skilled nursing facility - Current use of specific psychoactive medications (e.g.,certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); current use of warfarin (exclusionary for lumbar puncture) - Use of investigational agents one month prior to entry and for the duration of the trial - Participation in clinical studies involving neuropsychological measures being collected more than one time per year - Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1 - Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director

Gender: Both
Minimum Age: 55 Years
Maximum Age: 90 Years
Healthy Volunteers: Accepts Healthy Volunteers

Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

NCT ID: NCT00876863

The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people. Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure, while the other half will undergo a "placebo" surgery where no medication will be injected. All study participants will be followed for at least two years after surgery.

Condition:

Eligibility:

Inclusion Criteria: - Diagnosis of mild to moderate Alzheimer's disease - Approved medications for Alzheimer's disease may be taken if the dose has been stable for 3 months - A study partner who can attend all study visits - Good general health - Medically able to undergo neurosurgery Exclusion Criteria: - Significant neurological disease other than Alzheimer's disease - Significant depression or other psychiatric disorder - Unstable medical conditions

Gender: Both
Minimum Age: 55 Years
Maximum Age: 80 Years
Healthy Volunteers: No

Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

NCT ID: NCT00829374

The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

Condition:

Eligibility:

Inclusion Criteria: - Mild-to-moderate Alzheimer's disease - Probable AD (DSM-IV-TR) - MMSE score between 12 and 24, inclusive - Stable on donepezil for at least 6 months Exclusion Criteria: - Other causes of dementia - Major structural brain disease - Unstable medical condition or significant hepatic or renal disease

Gender: Both
Minimum Age: 50 Years
Maximum Age: N/A
Healthy Volunteers: No

An Extension of the CONCERT Protocol (DIM18)

NCT ID: NCT01152216

An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.

Condition:

Eligibility:

Inclusion Criteria: - Successful completion of the 12 month DIM18 CONCERT study - Mild-to-moderate Alzheimer's disease - Probable AD (DSM-IV-TR) - MMSE score between 12 and 24, inclusive - Stable on donepezil for at least 6 months Exclusion Criteria: - Other causes of dementia - Major structural brain disease - Unstable medical condition or significant hepatic or renal disease

Gender: Both
Minimum Age: 50 Years
Maximum Age: N/A
Healthy Volunteers: No

A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease

NCT ID: NCT00912288

No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

Condition:

This study was terminated on May 7, 2010 due to modification of the dimebon development plan following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Eligibility:

Inclusion Criteria: - Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease. - Have a Mini-Mental State Exam between 5 and 14 inclusive. - Have been taking the medication memantine (ie., Namenda) for at least six months prior to this study. - Must have a caregiver who assists the patient at least five days per week for at least three hours per day, who can accompany patient to study visits, and who has an intimate knowledge of the patient's health states and personal care. Exclusion Criteria: - Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil, rivastigmine, galantamine, tacrine) within 2 months prior to this study. - Dementia other than Alzheimers disease. - Any medical condition or reason that interferes with the ability of the patient to participate in or complete the trial or places the patient at undue risk, as judged by the study doctor.

Gender: Both
Minimum Age: 50 Years
Maximum Age: N/A
Healthy Volunteers: No

A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

NCT ID: NCT00937352

The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.

Condition:

Eligibility:

Inclusion Criteria: - Diagnosis of probable AD - Must have completed study 301 or study 302; and have completed Visit 15 (Week 78) - Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71 - Caregiver able to attend all clinic visits with patient Exclusion Criteria: - Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study - Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment - Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)

Gender: Both
Minimum Age: 51 Years
Maximum Age: N/A
Healthy Volunteers: No

Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)

NCT ID: NCT00574132

This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 230 study sites in the US and Canada and up to 35 sites outside of North America will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.

Condition:

Eligibility:

Inclusion Criteria: - Diagnosis of probable AD - Age from 50 to less than 89 - Mini-Mental Status Exam score of 16-26 inclusive - Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD - Stable doses of medications (cholinesterase inhibitors and memantine allowed) - Caregiver able to attend all clinic visits with patient Exclusion Criteria: - Significant neurological disease other than AD - Major psychiatric disorder - Significant systemic illness - History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years - Smoking greater than 20 cigarettes per day - Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications - Prior treatment experimental immunotherapeutics or vaccines for AD - Women of childbearing potential - Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Gender: Both
Minimum Age: 50 Years
Maximum Age: 88 Years
Healthy Volunteers: No

Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)

NCT ID: NCT00575055

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.

Condition:

Eligibility:

Inclusion Criteria: - Diagnosis of probable AD - Age from 50 to less than 89 - Mini-Mental Status Exam score of 16-26 inclusive - Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD - Stable doses of medications (cholinesterase inhibitors and memantine allowed) - Caregiver able to attend all clinic visits with patient Exclusion Criteria: - Significant neurological disease other than AD - Major psychiatric disorder - Significant systemic illness - History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years - Smoking greater than 20 cigarettes per day - Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications - Prior treatment experimental immunotherapeutics or vaccines for AD - Women of childbearing potential - Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Gender: Both
Minimum Age: 50 Years
Maximum Age: 88 Years
Healthy Volunteers: No

ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

NCT ID: NCT00934050

The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.

Condition:

Eligibility:

Inclusion Criteria: - This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication. Exclusion Criteria: - Subject has no new medical contraindications to continued participation in the study.

Gender: Both
Minimum Age: N/A
Maximum Age: N/A
Healthy Volunteers: No

A Study of V950 in People With Alzheimer Disease (V950-001 AM7)

NCT ID: NCT00464334

The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).

Condition:

Eligibility:

Inclusion Criteria: - Patient has mild to moderate Alzheimer Disease - Women cannot be able to get pregnant - Patient has a reliable caregiver, who will attend all visits and answer questions about the patient Exclusion Criteria: - Patient lives in a nursing home or facility - Patient has another neurological or neurodegenerative disorder - Patient has a history of stroke - Patient uses illicit drugs or has a history of drug/alcohol abuse - Patient has received blood or blood derived products within 6 months

Gender: Both
Minimum Age: 55 Years
Maximum Age: N/A
Healthy Volunteers: No