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Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)

NCT00329706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2017-05-02

No results posted yet for this study

Summary

A brain PET scan is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services, Decision Memo CAG-00088R, 2004), but evidence is less clear for patients having less severe cognitive problems. A substantial portion of such patients will develop Alzheimer's disease and other forms of dementia, which affect millions of people in the U.S., costing us over $100 billion annually. This project employs a prospective randomized protocol to determine whether PET scanning can help distinguish those patients with early Alzheimer's changes in their brains from those having other causes of cognitive impairment more accurately than is done with current clinical practices alone, and lead to earlier, more effective therapies which extend patients' abilities to think and function independently.

Conditions

Interventions

PROCEDURE

FDG-PET brain scan

The difference in the two arms' interventions is the time at which the FDG-PET brain scan information is available for the subjects' managing physicians. Experimental arms will have an immediate release of the PET report, while the Active Comparator arms will have a delayed release of 2 years.

Sponsors & Collaborators

Principal Investigators

  • Daniel H Silverman, MD, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00329706 on ClinicalTrials.gov