| Sponsor |
National Institute on Aging (NIA)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Foundation for the National Institutes of Health
Institute for the Study of Aging (ISOA)
Alzheimer's Association |
| Official Study Title |
Alzheimer's Disease Neuroimaging Study (ADNI) |
| Conditions Studied |
Healthy Adults , Mild Cognitive Impairment and Alzheimer's disease
|
| Purpose |
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. |
| 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
- 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.
|
| Testing |
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 samples for analysis and storage
for future analyses. |
| Frequency of Visits |
MCI and normal controls will be followed for 3 years, AD participants
will be followed for 2 years at 6 month intervals. |
| Materials Needed Prior to Evaluation |
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