Trial Search Results

Alzheimer's Disease Neuroimaging Initiative 2

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

University of Southern California

Collaborator: Alzheimer's Therapeutic Research Institute

Stanford Investigator(s):

Intervention(s):

  • Drug: Florbetapir
  • Drug: Flortaucipir

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.

Ages Eligible for Study

55 Years - 90 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michael Nolasco
650-849-0491
Not Recruiting