Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Predictors of Cognitive Decline in Normal Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00094939
Recruitment Status : Unknown
Verified September 2009 by National Institute on Aging (NIA).
Recruitment status was:  Recruiting
First Posted : October 29, 2004
Last Update Posted : December 14, 2009
Information provided by:
National Institute on Aging (NIA)

Brief 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.

Condition or disease
Alzheimer Disease Dementia

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 170 participants
Time Perspective: Prospective
Official Title: Predictors of Cognitive Decline in Normal Aging
Study Start Date : September 2003
Study Completion Date : August 2008

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00094939

Layout table for location contacts
Contact: Kenneth E. Rich 212-263-7563

Layout table for location information
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)
Layout table for investigator information
Principal Investigator: Mony J. de Leon, Ed.D. Center for Brain Health, Silberstein Institute
Layout table for additonal information Identifier: NCT00094939    
Other Study ID Numbers: IA0056
R01AG012101 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2004    Key Record Dates
Last Update Posted: December 14, 2009
Last Verified: September 2009
Keywords provided by National Institute on Aging (NIA):
mild cognitive impairment
Alzheimer disease
magnetic resonance imaging
CSF tau protein
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders