We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PET Changes in Alzheimer's Disease (AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00094913
Recruitment Status : Unknown
Verified July 2007 by National Institute on Aging (NIA).
Recruitment status was:  Active, not recruiting
First Posted : October 29, 2004
Last Update Posted : May 27, 2009
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
The purpose of this study is to identify the earliest predictors of memory and brain deterioration in pre-clinical Alzheimer's disease using positron emission tomography (PET) to monitor brain glucose metabolism.

Condition or disease
Alzheimer Disease

Detailed Description:

Previous studies indicate that the brain's glucose metabolism rate potentially may be an early indicator of damage to particular regions of the brain caused by AD, including loss of neurons, synapses, and other changes. Many of these changes are reported among patients with mild cognitive impairment (MCI), a group known to be at increased risk for AD.

The overall goal of this study is to use FDG-PET (2-[(18)F]fluoro-2-deoxy-d-glucose/positron-emission tomography) to determine whether metabolic abnormalities in the hippocampus predict memory and brain deterioration in middle age, and to identify the brain glucose metabolism predictors of future MCI.

Participants in the study will be grouped into 3 main groups of 35 each, including young individuals (20-40 years of age), 41-90 year-old normal, and MCI individuals with or without risk for memory decline. Participants will undergo baseline and 36-month follow-up exams to include comprehensive medical, neurologic, and psychiatric evalutions; lumbar puncture; a resting FDG-PET; an MRI scan; and a neuropsychological battery. A brief medical exam, full neuropsychological battery, and MRI scan will be administered at 18 months. Two subgroups (groups 4 and 5) of 15 each will be created from groups 1 and 2 at 18 months to participate in the evaluation of memory performance under acute hyperglycemia and saline challenges and effects on hippocampal formation and glucose metabolism.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 105 participants
Time Perspective: Prospective
Official Title: Clinical Correlates of Longitudinal PET Changes in Alzheimer's Disease (AD)
Study Start Date : May 2004
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine






Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females with a minimum high school education and between the ages of 50 and 90 will be selected for Groups 1 and 2. For Group 3, normal subjects between the ages of 20 and 49 years of age will be selected. The Groups 1 and 2 will be balanced for age, and all three groups balanced for gender and ApoE genotype.
  • Discontinuance of all psychotropic and/or cognitively active medication at least four weeks prior to evaluation.

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.
  • Any 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, indicative of 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 hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions. Specific exclusion will be made for individuals with fasting glucose levels >110 mg/dl.
  • 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.
  • Evidence of cognitive or memory impairment reaching early AD levels at the initial evaluation. At baseline, delayed paragraph recall z-scores > 2 below the reference group.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094913


Locations
Layout table for location information
United States, New York
Center for Brain Health, Silberstein Institute, New York University
New York City, New York, United States, 10016
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Mony J. de Leon, Ed.D. Center for Brain Health, Silberstein Institute
Publications:
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00094913    
Other Study ID Numbers: IA0055
R01AG013616 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2004    Key Record Dates
Last Update Posted: May 27, 2009
Last Verified: July 2007
Keywords provided by National Institute on Aging (NIA):
Aging
Mild Cognitive Impairment
Alzheimer disease, preclinical
Hippocampal formation
Glucose metabolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders