NCT00094952

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2004

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

First QC Date

October 28, 2004

Last Update Submit

September 16, 2009

Conditions

Alzheimer's Disease

Keywords

Mild Cognitive ImpairmentAlzheimer's diseasemagnetic resonance imagingcerebrospinal fluid (CSF) biomarkers

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New York, New York, 10016, United States

RECRUITING

Related Publications (3)

  • Rusinek H, De Santi S, Frid D, Tsui WH, Tarshish CY, Convit A, de Leon MJ. Regional brain atrophy rate predicts future cognitive decline: 6-year longitudinal MR imaging study of normal aging. Radiology. 2003 Dec;229(3):691-6. doi: 10.1148/radiol.2293021299.

    PMID: 14657306BACKGROUND

  • Buerger K, Teipel SJ, Zinkowski R, Blennow K, Arai H, Engel R, Hofmann-Kiefer K, McCulloch C, Ptok U, Heun R, Andreasen N, DeBernardis J, Kerkman D, Moeller H, Davies P, Hampel H. CSF tau protein phosphorylated at threonine 231 correlates with cognitive decline in MCI subjects. Neurology. 2002 Aug 27;59(4):627-9. doi: 10.1212/wnl.59.4.627.

    PMID: 12196665BACKGROUND

  • de Leon MJ, Segal S, Tarshish CY, DeSanti S, Zinkowski R, Mehta PD, Convit A, Caraos C, Rusinek H, Tsui W, Saint Louis LA, DeBernardis J, Kerkman D, Qadri F, Gary A, Lesbre P, Wisniewski T, Poirier J, Davies P. Longitudinal cerebrospinal fluid tau load increases in mild cognitive impairment. Neurosci Lett. 2002 Nov 29;333(3):183-6. doi: 10.1016/s0304-3940(02)01038-8.

    PMID: 12429378BACKGROUND

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Mony J. de Leon, Ed.D.

    Center for Brain Health, Silberstein Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth E. Rich

CONTACT

212-263-7563kenneth.rich@med.nyu.edu

Anna Hemraj

CONTACT

212-263-1091dhanmatie.hemraj@nyumc.org

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

October 28, 2004

First Posted

October 29, 2004

Study Start

April 1, 2003

Study Completion

March 1, 2008

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

US(1)