Biomarkers and Early Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00094952
First received: October 28, 2004
Last updated: September 16, 2009
Last verified: September 2009
  Purpose

The main goal of this project is to use imaging and biomarkers to identify cognitively normal elderly people who are at increased risk for developing mild cognitive impairment (MCI). MCI is the earliest clinically detectable evidence for brain changes due to Alzheimer's disease (AD). The second goal of this project is to describe the inter-relationships among anatomical biomarkers, cerebrospinal fluid biomarkers, and cognition measures in those elderly people who develop MCI.


Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Biomarkers and Early Alzheimer's Disease

Resource links provided by NLM:


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

Estimated Enrollment: 80
Study Start Date: April 2003
Estimated Study Completion Date: March 2008
Detailed Description:

The goal of this project is to use magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF) biomarkers to identify cognitively normal participants who show the earliest clinically detectable brain changes of Alzheimer's disease (AD).

The major hypothesis for this study is that CSF P-tau231 measurement improves the accuracy of MRI and cerebrospinal fluid (CSF) measurements in predicting mild cognitive impairment (MCI). Validation of this hypothesis can lead to improved diagnostic tools for detecting AD as early as possible.

This 5-year longitudinal study will involve a baseline exam and two 18-month followup exams. Participants will undergo MRI scans, CSF collection and blood samples, neuropsychological performance testing, and medical, neurological and psychiatric assessment. The screening and diagnostic evaluations will be carried out by the New York University Alzheimer Disease Core Center (ADCC) and the NYU Center for Brain Health.

This study will enroll a minimum of 80 cognitively normal participants, 60 to 80 years of age, with English as their first language, with about 12 years of formal education, and who are living in the metropolitan New York City area. All participants will receive baseline and follow-up evaluations to rule out confounding medical, neurological, and psychiatric conditions that could affect cognition. The study coordinator will maintain 6-month telephone contact with all participants and their caregivers who are part of the project.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals of either sex, with a high school education, and between the ages of 60 and 80 years living in the New York City metropolitan area.
  • Minimum of 12 years education.
  • Participants will be classified as within normal limits on medical, psychiatric and neuropsychological examinations (performance that is better than -1.5 sd of the NYU norm based WMS-R delayed memory index).
  • Participants will have a global deterioration scale (GDS)=1 or 2. Those enrolled in the High-Risk group will have a GDS=2 and have a score of >25 on the Memory Complaint Questionnaire (MCQ). In high risk memory loss cases, an informed family member or caregiver will be interviewed to confirm that the participant can perform specific tasks.

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, Post-Traumatic Stress Disorder [PTSD], or depression).
  • Any focal neurological signs or significant neuropathology.
  • A score of 4 or greater on the Modified Hachinski Ischemia Scale, indicative of 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 ClinicalTrials.gov identifier: NCT00094952

Contacts
Contact: Kenneth E. Rich 212-263-7563 kenneth.rich@med.nyu.edu
Contact: Anna Hemraj 212-263-1091 dhanmatie.hemraj@nyumc.org

Locations
United States, New York
Center for Brain Health, Silberstein Institute, New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Kenneth E. Rich    212-263-7563    kenneth.rich@med.nyu.edu   
Principal Investigator: Mony J. de Leon, Ed.D.         
Sponsors and Collaborators
Investigators
Principal Investigator: Mony J. de Leon, Ed.D. Center for Brain Health, Silberstein Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00094952     History of Changes
Other Study ID Numbers: IA0054, AG022374
Study First Received: October 28, 2004
Last Updated: September 16, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Mild Cognitive Impairment
Alzheimer's disease
magnetic resonance imaging
cerebrospinal fluid (CSF) biomarkers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014