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Evaluation of Age- and Alzheimer's Disease-Related Memory Disorder

Primary Purpose

Alzheimer Disease, Dementia, Memory Disorder

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Spectroscopy, Longitudinal, Perfusion, Hippocampus, N-acetylaspartic Acid, Cerebral Blood Flow, Aging, Dementia, Alzheimer's, Memory Disorder, Memory, Healthy Volunteer, HV, Normal Control

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: Patients will be referred through the GPB screening protocol 95-M-0096: Subjects will include: AD patients, diagnosis based on DSM-IV (APA Press, 1994) criteria, Individuals over the age of 50 who are "at-risk" for AD on the basis of having first-degree relatives with AD and who tested within the normal range on a battery of cognitive tests at the time of initial inclusion, Individuals with mild cognitive impairment (memory problems significant enough to concern the individual or members of the individual's family who do not meet the criteria for AD), Control subjects, individuals without a positive family history of dementia in their first degree relatives and who test within the normal range on the battery of cognitive tests. As part of this screening process subjects who medical histories significant for any medical condition that would make it unsafe to perform MRI scans will be excluded. EXLCUSION CRITERIA: The same exclusion criteria used in those protocols for structural MRI and delineated under Hazards and Precautions would again be used. All subjects participating in functional MRI scans will be required to be off prescription medications which could effect these scans, such as medications with anticholinergic effects, for two weeks-to one month prior to PET scan, and off psychotropic medication for one month. Withdrawal from psychotropic medications for purposes of participation in this protocol would only be considered for individuals already involved in the Longitudinal Study Protocol 95-M-0096. Subjects will be cautioned not to consume alcohol, marijuana, or psychotropic drugs while on the study, nor to smoke, use caffeinated beverages, or take over-the counter medications such as cold medications (i.e.: benadryl, sudafed) for at least 12 hours prior to the functional MRI scans. Pregnancy test will be conducted prior to MRI scans on women of childbearing age.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 5, 2002
Last Updated
June 30, 2017
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00029120
Brief Title
Evaluation of Age- and Alzheimer's Disease-Related Memory Disorder
Official Title
MRI Contrast Imaging in the Evaluation and Follow-up of Patients With Memory Disorder and Healthy Controls
Study Type
Observational

2. Study Status

Record Verification Date
April 21, 2008
Overall Recruitment Status
Completed
Study Start Date
December 18, 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 21, 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to examine how a part of the brain called the hippocampus contributes to memory changes that occur with aging and Alzheimer's disease (AD). Memory problems are the most important early symptoms of AD. The hippocampal region of the brain may be responsible for many age- and AD-related memory disorders. This study will use magnetic resonance imaging (MRI) scans to examine the structure, chemical composition, and function of the hippocampus in participants with AD, participants with mild memory problems, participants who are healthy but are at risk for AD, and healthy volunteers. Participants in this study will undergo MRI scans of the brain. During the MRI, participants will perform memory tests to demonstrate hippocampal functioning.
Detailed Description
The major focus of the Geriatric Psychiatry Branch (GPB) is the study of individuals with memory disorders as a result of age or neurodegeneration. In particular, memory is the most important earliest clinical symptom of Alzheimer's disease (AD). Although the hippocampus may not be a biological determinant of all memories, there is a growing body of evidence suggesting that dysfunction of the hippocampus plays an important role in the most common forms of memory disorders. This proposal will allow for the application of an array of newly developed magnetic resonance imaging and spectroscopy methods to the study of hippocampal function in these patients. Most importantly, for the first time, structure, perfusion and neurochemical composition of the hippocampus in living individuals can be evaluated at high resolution without known risk. The study of longitudinal changes in hippocampal function should allow us to understand the contributions that various genotypes, e.g., ApoE4, and abnormalities in cerebrospinal fluid, e.g., A-beta42 and tau, play in the development of abnormal hippocampal structure and function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia, Memory Disorder, Healthy
Keywords
Alzheimer's Disease, Spectroscopy, Longitudinal, Perfusion, Hippocampus, N-acetylaspartic Acid, Cerebral Blood Flow, Aging, Dementia, Alzheimer's, Memory Disorder, Memory, Healthy Volunteer, HV, Normal Control

7. Study Design

Enrollment
450 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Patients will be referred through the GPB screening protocol 95-M-0096: Subjects will include: AD patients, diagnosis based on DSM-IV (APA Press, 1994) criteria, Individuals over the age of 50 who are "at-risk" for AD on the basis of having first-degree relatives with AD and who tested within the normal range on a battery of cognitive tests at the time of initial inclusion, Individuals with mild cognitive impairment (memory problems significant enough to concern the individual or members of the individual's family who do not meet the criteria for AD), Control subjects, individuals without a positive family history of dementia in their first degree relatives and who test within the normal range on the battery of cognitive tests. As part of this screening process subjects who medical histories significant for any medical condition that would make it unsafe to perform MRI scans will be excluded. EXLCUSION CRITERIA: The same exclusion criteria used in those protocols for structural MRI and delineated under Hazards and Precautions would again be used. All subjects participating in functional MRI scans will be required to be off prescription medications which could effect these scans, such as medications with anticholinergic effects, for two weeks-to one month prior to PET scan, and off psychotropic medication for one month. Withdrawal from psychotropic medications for purposes of participation in this protocol would only be considered for individuals already involved in the Longitudinal Study Protocol 95-M-0096. Subjects will be cautioned not to consume alcohol, marijuana, or psychotropic drugs while on the study, nor to smoke, use caffeinated beverages, or take over-the counter medications such as cold medications (i.e.: benadryl, sudafed) for at least 12 hours prior to the functional MRI scans. Pregnancy test will be conducted prior to MRI scans on women of childbearing age.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10567488
Citation
Alvarez R, Alvarez V, Lahoz CH, Martinez C, Pena J, Sanchez JM, Guisasola LM, Salas-Puig J, Moris G, Vidal JA, Ribacoba R, Menes BB, Uria D, Coto E. Angiotensin converting enzyme and endothelial nitric oxide synthase DNA polymorphisms and late onset Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1999 Dec;67(6):733-6. doi: 10.1136/jnnp.67.6.733.
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Evaluation of Age- and Alzheimer's Disease-Related Memory Disorder

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