Predictors of Cognitive Decline in Normal Aging

Last updated: December 10, 2009
Sponsor: National Institute on Aging (NIA)
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Dementia

Mild Cognitive Impairment

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00094939
IA0056
R01AG012101
  • Ages 60-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this project is to develop an early diagnostic test for Alzheimer's disease (AD) by monitoring loss of neurons and brain size reductions over a period of five years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females, from all racial and ethnic categories between the ages of 60-80years of age, with English as their first language.

  • Residents of the New York City metropolitan area.

  • Minimum of 12 years of education.

  • Participants will be grouped according to the following classifications: normal aging,mild cognitive impairment (MCI), Alzheimer's disease (AD), or frontotemporal dementia (FTD).

  • Participants will agree to ApoE genotyping and DNA banking.

Exclusion

Exclusion Criteria:

  • Past history or MRI evidence of brain damage including significant trauma, stroke,hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurologicaldisorder.

  • Significant history of alcoholism or drug abuse.

  • History of psychiatric illness (e.g., schizophrenia, mania or depression).

  • Any focal signs or significant neuropathology.

  • A score of 4 or greater on the Modified Hachinski Ischemia Scale suggestingcerebrovascular disease.

  • A total score of 16 or more on the Hamilton Depression Scale to exclude possible casesof primary depression.

  • Evidence of clinically relevant and uncontrolled hypertensive, cardiac, pulmonary,vascular, metabolic or hematologic conditions.

  • Physical impairment of such severity as to adversely affect the validity ofpsychological testing.

  • Hostility or refusal to cooperate.

  • Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected bythe magnetic field employed during MRI imaging.

  • History of familial early onset dementia.

Study Design

Total Participants: 170
Study Start date:
September 01, 2003
Estimated Completion Date:
August 31, 2008

Study Description

Studies of normal aging and mild cognitive impairment (MCI) show that loss of neurons and reduction in size of the hippocampal part of the brain predict a person's conversion from MCI to Alzheimer's disease (AD). Increases in tangle-related abnormal tau proteins, specifically P-tau231, also appear to be related.

This study will collect neuropsychological data, magnetic resonance imaging (MRI), and cerebrospinal fluid (CSF) from volunteer participants to measure the relationship between changes in brain volume, CSF levels, and memory performance.

From the data researchers hope to develop an early diagnostic test for AD.

The study will include 170 participants between the ages of 60 and 80 years, some normal, some with MCI, some with mild AD, and some with frontotemporal dementia. After initial screening of volunteers, the researchers will give participants a complete baseline exam and 24-month follow-up exams over a period of five years.

Connect with a study center

  • Center for Brain Health, Silberstein Institute, New York University School of Medicine

    New York City, New York 10016
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.