Predictors of Cognitive Decline in Normal Aging | NCT00094939

Studies
Predictors of Cognitive Decline in Normal Aging

NCT00094939

Sponsor

National Institute on Aging (NIA)

Status

Unknown status

Last Update Posted

Dec 14, 2009Estimated

Enrollment

170Estimated

Phase

Not provided

Conditions

Alzheimer Disease
Dementia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AG012101	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Aug 2008

First Submitted Date

Oct 28, 2004

First Submission Date that Met QC Criteria

Oct 28, 2004

First Posted Date

Oct 29, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2009

Last Update Posted Date

Dec 14, 2009Estimated

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kenneth E. Rich	Contact	212-263-7563		kenneth.rich@med.nyu.edu

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Brain Health, Silberstein Institute, New York University School of Medicine	Recruiting	New York	New York	10016	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12429378	Background	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.
12196665	Background	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.

ID	Term
D000544	Alzheimer Disease
D003704	Dementia
D060825	Cognitive Dysfunction

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies