NCT00094939

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.

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
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

September 1, 2003

Completed
1.2 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
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 14, 2009

Status Verified

September 1, 2009

First QC Date

October 28, 2004

Last Update Submit

December 10, 2009

Conditions

Alzheimer DiseaseDementia

Keywords

mild cognitive impairmentAlzheimer diseasemagnetic resonance imagingCSF tau proteinHippocampus

Eligibility Criteria

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

You may qualify if:

  • 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.

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 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.

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 (4)

  • 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

  • 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

  • Mehta PD, Pirttila T, Mehta SP, Sersen EA, Aisen PS, Wisniewski HM. Plasma and cerebrospinal fluid levels of amyloid beta proteins 1-40 and 1-42 in Alzheimer disease. Arch Neurol. 2000 Jan;57(1):100-5. doi: 10.1001/archneur.57.1.100.

    PMID: 10634455BACKGROUND

  • Haghdel A, Smith N, Glodzik L, Li Y, Wang X, Crowder T, Zhu YS, Butler T, Blennow K, McIntire LB, Pahlajani S, Osborne J, Chiang G, de Leon M, Ivanidze J. Evidence of Pericyte Damage in a Cognitively Normal Cohort: Association With CSF and PET Biomarkers of Alzheimer Disease. Alzheimer Dis Assoc Disord. 2024 Apr-Jun 01;38(2):107-111. doi: 10.1097/WAD.0000000000000623. Epub 2024 May 16.

    PMID: 38752577DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain 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

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

September 1, 2003

Study Completion

August 1, 2008

Last Updated

December 14, 2009

Record last verified: 2009-09

Locations

US(1)