Status:
UNKNOWN
Implications of Amyloid Pathology
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60-90 years
Brief Summary
The purpose of this study is to determine whether asymptomatic older individuals with high amyloid burden will subsequently manifest cognitive impairment and eventually progress to clinical Alzheimer'...
Detailed Description
There is compelling evidence supporting amyloid as one of the key pathologic agents in AD. Autopsy studies suggest the amount and location of fibrillar amyloid deposition does not relate strongly to t...
Eligibility Criteria
Inclusion
- Age range from 60 to 90 years
- Clinical Dementia Rating (CDR) Score of 0
- Mini Mental State Exam of 27-30
- A study partner who can answer questions pertaining to daily functioning
- Perform within 1.5 standard deviation of age and education matched norms on screening tests of attention and executive function, language, visuospatial perception and episodic memory
- Stable medications for at least 30 days
- Fluent in English
- Modified Hachinski Score of \<4
- Geriatric Depression Scale Score \<10
Exclusion
- Diagnosis of MCI or dementia
- Individuals with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia)
- Unstable medications or on medications with CNS effects including cholinesterase inhibitors, memantine, and antidepressants
- Major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder, or treatment with ECT (mild depression that is well treated with stable dose of SSRI antidepressants will be allowed)
- Multiple sclerosis or other autoimmune disorders
- Huntington's disease
- Head injury, post-traumatic dementia or seizures
- Metabolic encephalopathy, CNS infection, hydrocephalus
- Cardiovascular disease, stroke, congestive heart failure
- Substance abuse within the past 2 years
- Active cancer
- Active hematological, renal, pulmonary, endocrine or hepatic disorders
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00900770
Start Date
November 1 2008
End Date
March 1 2014
Last Update
December 29 2009
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115