Alzheimer's Disease Neuroimaging Initiative 2

• Register: ClinicalTrials.gov
• Last refreshed on: 25 February 2013
• Main ID: NCT01231971
• Date of registration: 27/10/2010
• Primary sponsor: Alzheimer's Disease Cooperative Study (ADCS)
• Public title: Alzheimer's Disease Neuroimaging Initiative 2 ADNI2
• Scientific title: Alzheimer's Disease Neuroimaging Initiative 2
• Date of first enrolment: January 2011
• Target sample size: 650
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01231971
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Prospective

Countries of recruitment

Canada, United States

Contacts

• Name: Jeffree Itrich

• Name: Ronald Petersen, MD, PhD
• Affiliation: Mayo Clinic

• Name: Paul S. Aisen, MD
• Affiliation: University of California, San Diego

• Name: Michael W. Weiner, MD
• Affiliation: University of California, San Francisco

Key inclusion & exclusion criteria

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


Age minimum: 55 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Mild Cognitive Impairment (MCI)

Primary Outcome(s)

Rate of volume change of whole brain, hippocampus and other structural MRI measures [Time Frame: 4 Years]

Secondary Outcome(s)

APOE genotype, low CSF Aß42, positive amyloid imaging with Florbetapir F 18 [Time Frame: 4 Years]

Correlations among biomarkers and biomarker change [Time Frame: 4 Years]

Extent of amyloid deposition as measured by Florbetapir F 18 [Time Frame: 4 Years]

Group differences for each imaging and biomarker measurement [Time Frame: 4 Years]

Rate of conversion will be evaluated among all five groups [Time Frame: 4 Years]

Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes [Time Frame: 4 Years]

Rates of change of glucose metabolism (FDG-PET) [Time Frame: 4 Years]

Rates of change on each specified biochemical biomarker [Time Frame: 4 Years]

Secondary ID(s)

ADC-039-ADNI2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute on Aging (NIA)

Northern California Institute for Research and Education (NCIRE)