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Predictors of Cognitive Decline in Normal Aging

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by National Institute on Aging (NIA).
Recruitment status was:  Recruiting
Information provided by:
National Institute on Aging (NIA) Identifier:
First received: October 28, 2004
Last updated: December 10, 2009
Last verified: September 2009
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.

Alzheimer Disease Dementia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Predictors of Cognitive Decline in Normal Aging

Resource links provided by NLM:

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 170
Study Start Date: September 2003
Estimated Study Completion Date: August 2008
Detailed 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.


Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males and females, from all racial and ethnic categories between the ages of 60-80 years 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 Criteria:

  • Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder.
  • 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 suggesting cerebrovascular disease.
  • A total score of 16 or more on the Hamilton Depression Scale to exclude possible cases of 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 of psychological testing.
  • Hostility or refusal to cooperate.
  • Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by the magnetic field employed during MRI imaging.
  • History of familial early onset dementia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00094939

Contact: Kenneth E. Rich 212-263-7563

United States, New York
Center for Brain Health, Silberstein Institute, New York University School of Medicine Recruiting
New York City, New York, United States, 10016
Contact: Kenneth E. Rich    212-263-7563   
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: Mony J. de Leon, Ed.D. Center for Brain Health, Silberstein Institute
  More Information

Publications: Identifier: NCT00094939     History of Changes
Other Study ID Numbers: IA0056
R01AG012101 ( U.S. NIH Grant/Contract )
Study First Received: October 28, 2004
Last Updated: December 10, 2009

Keywords provided by National Institute on Aging (NIA):
mild cognitive impairment
Alzheimer disease
magnetic resonance imaging
CSF tau protein

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on August 21, 2017