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Predictors of Cognitive Decline in Normal Aging - Article


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Dementia - Subcortical


Clinical Trial: Predictors of Cognitive Decline in Normal Aging

This study is currently recruiting patients.

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)

Purpose

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 Phase
Alzheimer Disease
Dementia
Phase II

MedlinePlus related topics:  Alzheimer's Caregivers;   Alzheimer's Disease;   Dementia
Genetics Home Reference related topics:  Alzheimer disease

Study Type: Observational
Study Design: Screening, Longitudinal, Case Control, Prospective Study

Further Study Details: 

Expected Total Enrollment:  170

Study start: September 2003;  Expected completion: August 2008

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.

Eligibility

Ages Eligible for Study:  60 Years   -   80 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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.

Location and Contact Information

Kenneth E. Rich      212-263-7563    kenneth.rich@med.nyu.edu

New York
      Center for Brain Health, Silberstein Institute, New York University School of Medicine, New York City,  New York,  10016,  United States; Recruiting
Kenneth E. Rich  212-263-7563    kenneth.rich@med.nyu.edu 

Study chairs or principal investigators

Mony J. de Leon, Ed.D.,  Principal Investigator,  Center for Brain Health, Silberstein Institute   

More Information

Publications

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.

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.

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.

Study ID Numbers:  IA0056; R01 AG12101
Record last reviewed:  October 2004
Last Updated:  October 29, 2004
Record first received:  October 28, 2004
ClinicalTrials.gov Identifier:  NCT00094939
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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August 29, 2008



Page Updated: September 6, 2005
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