NCT00029120

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 18, 2001

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2002

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2008

Completed
Last Updated

July 2, 2017

Status Verified

April 21, 2008

First QC Date

January 5, 2002

Last Update Submit

June 30, 2017

Conditions

Keywords

Alzheimer's DiseaseSpectroscopyLongitudinalPerfusionHippocampusN-acetylaspartic AcidCerebral Blood FlowAgingDementiaAlzheimer'sMemory DisorderMemoryHealthy VolunteerHVNormal Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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:

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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.

    PMID: 10567488BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDementiaMemory Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 5, 2002

First Posted

January 7, 2002

Study Start

December 18, 2001

Study Completion

April 21, 2008

Last Updated

July 2, 2017

Record last verified: 2008-04-21

Locations