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Status unknownNCT00094913Updated May 27, 2009

PET Changes in Alzheimer's Disease (AD)

An observational study in Alzheimer Disease, sponsored by National Institute on Aging (NIA). Status unknown at 1 site in United States. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-05-27.

Sponsored by National Institute on Aging (NIA) · Observational

The sponsor has not verified this record recently (last verified Jul 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
105
Ages
20 Years to 90 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Alzheimer Disease

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Keywords

  • Aging
  • Mild Cognitive Impairment
  • Alzheimer disease, preclinical
  • Hippocampal formation
  • Glucose metabolism
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 105 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

National Institute on Aging (NIA) is the lead sponsor of 157 studies on the registry; 13 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Time perspective
Prospective
Enrollment
105 participants (estimated)
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Study locations

1 site
  • Center for Brain Health, Silberstein Institute, New York University
    New York City, New York 10016, United States
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References and documents

Publications

  • de Leon MJ, Convit A, Wolf OT, Tarshish CY, DeSanti S, Rusinek H, Tsui W, Kandil E, Scherer AJ, Roche A, Imossi A, Thorn E, Bobinski M, Caraos C, Lesbre P, Schlyer D, Poirier J, Reisberg B, Fowler J. Prediction of cognitive decline in normal elderly subjects with 2-[(18)F]fluoro-2-deoxy-D-glucose/poitron-emission tomography (FDG/PET). Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10966-71. doi: 10.1073/pnas.191044198. Epub 2001 Aug 28. PubMed 11526211 ↗
  • Bobinski M, de Leon MJ, Convit A, De Santi S, Wegiel J, Tarshish CY, Saint Louis LA, Wisniewski HM. MRI of entorhinal cortex in mild Alzheimer's disease. Lancet. 1999 Jan 2;353(9146):38-40. doi: 10.1016/s0140-6736(05)74869-8. No abstract available. PubMed 10023955 ↗
  • De Santi S, de Leon MJ, Rusinek H, Convit A, Tarshish CY, Roche A, Tsui WH, Kandil E, Boppana M, Daisley K, Wang GJ, Schlyer D, Fowler J. Hippocampal formation glucose metabolism and volume losses in MCI and AD. Neurobiol Aging. 2001 Jul-Aug;22(4):529-39. doi: 10.1016/s0197-4580(01)00230-5. PubMed 11445252 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00094913
Lead sponsor
National Institute on Aging (NIA)
First posted
Oct 29, 2004
Start date
May 2004
Completion
Apr 2005
Last update
May 27, 2009

Study contacts

Mony J. de Leon, Ed.D.
principal investigator · Center for Brain Health, Silberstein Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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