Protocol Number: 95-M-0096

Title:

The Evaluation and Follow-up of Patients with Memory Disorder and Normal Controls

Number:

95-M-0096

Summary:

The purpose of this study is to evaluate people with mild memory problems, those with dementia, those at risk for developing Alzheimer's disease (AD), and healthy volunteers to identify markers of AD before the changes that occur with the disease begin.

The origin and markers of progression for Alzheimer's disease (AD) are relatively obscure. Despite increased understanding of the underlying biology of AD, its clinical diagnosis is still made only after progressive cognitive decline; definitive diagnosis is confirmed at autopsy. This study will examine biomarker changes over time in a distinct cohort of people with an increased risk of developing AD. The study will also identify and track biological changes that occur with progressive dementia and compare those changes to the known cognitive and emotional disturbances that characterize AD.

Individuals with a first-degree relative with AD will be recruited into an at-risk cohort. They will be followed and compared to a group of healthy volunteers for a minimum of 8 years.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION AND EXCLUSION CRITERIA:

DEMENTIA PATIENTS:

Dementia of the Alzheimer type will be defined by a gradual onset with a continuing cognitive decline not due to other central nervous system conditions that cause progressive deficits in memory. The cognitive decline must include a memory impairment but must also be accompanied by at least one other cognitive disturbance such as aphasia, apraxia, agnosia, or a disturbance in executive functioning. The deficits must cause significant impairments in social or occupational performance and represent a decline in function.

Longitudinal subjects will be excluded from specific aspects of the study if they have contraindications to any of the procedures involved as specified in the Hazards and Precautions section. Furthermore, subjects will be excluded if they are not able or willing to assign durable power of attorney (DPA) to an appropriate person.

MILD COGNITIVE IMPAIRMENT (MCI):

Is defined operationally as evidence of cognitive difficulty, including memory problems which are significant to generate a worry for the individual or surrounding family members but not yet sufficient to elicit the diagnosis of possible Alzheimer's disease when evaluated by a physician. As in the Alzheimer's Disease Cooperative Study, these subjects will have a memory complaint and at least one abnormal memory function, but they will still fall within normal limits globally.

AT RISK INDIVIDUALS:

At risk individuals will be defined by one of the following criteria: (a) having a presumptive diagnosis of AD in one or more of their first-degree relatives; or (b) belonging to a family with a known or presumed genetic mutation for AD; and (c) testing within the normal range on a battery of cognitive tests at the time of baseline evaluation.

NORMAL CONTROLS:

They will not have a positive family history of dementia in their first-degree relatives, and they will test within the normal range on the battery of cognitive tests listed previously.

Special Instructions:

Referral letter is required for normal volunteers and individuals with memory deficits.

Keywords:

Dementia

Alzheimer's Disease

Cerebrospinal Fluid

Diagnostic Test

Cognitive Testing

Recruitment Keywords:

Memory Disorder

Normal Volunteer

Conditions:

Alzheimer's Disease

Dementia

Healthy

Memory Disorder

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

P. Trey Sunderland III, M.D.
National Institutes of Health
Building 10
Room 3N218
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 496-0948
Fax: (301) 435-6051

Electronic Address: trey@helix.nih.gov

Citations:

CSF somatostatin in patients with Alzheimer's disease, older depressed patients, and age-matched control subjects

The consortium to establish a registry for Alzheimer's disease (CERAD) Part II Standardization of the neuropathologic assessment of Alzheimer's disease

Autonomic dysfunction in patients with dementia of the alzheimer type

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Bethesda, Maryland 20892. Last update: 10/16/2004