Search / Trial NCT00001480

The Evaluation and Follow-up of Individuals With Memory Disorder

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Dementia Alzheimer's Disease Cerebrospinal Fluid Diagnostic Test Cognitive Testing Memory Disorder Normal Volunteer

Description

The temporal origin of Alzheimer's disease (AD) and markers of progression of this disease process are relatively obscure. Despite outstanding advances in the understanding of the underlying biology of AD, the clinical diagnosis is still made by consensus following progressive cognitive deterioration and confirmed only at autopsy. The protocol will serve two functions. First, we will evaluate and longitudinally follow a cohort of first-degree relatives of AD subjects who are currently normal but are at increased risk of developing AD sometime in the future. This cohort will be compared to a...

Gender

All

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.

Attachments

readout_NCT00001480_2023-12-10.pdf

4.5 MB

NCT00001480_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Pittsburgh, Pennsylvania, United States

Washington, D.C., District Of Columbia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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