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Molecular Cerebral Imaging in Incipient Dementia (MCI-ID) II

NCT02317250 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-10-15

No results posted yet for this study

Summary

A substantial portion of people covered by Medicare will develop Alzheimer's disease and other forms of dementia that together devastate the lives of millions of people in the United States, and cost us a total of over $200 billion every year. Getting a brain scan with a PET scanner to look for abnormal brain metabolism patterns is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services (CMS), Decision Memo CAG-00088R), but the evidence is considered less clear for patients having less severe cognitive problems, and/or for patients getting a brain scan with a PET scanner to look for abnormal proteins in the brain (CMS Decision Memo CAG-00431N). This project employs a scientifically rigorous design (prospective, multi-centered, randomized controlled trial) to determine whether such PET scanning can help distinguish more accurately than is being done in current clinical practice those patients with early molecular changes in their brains who will benefit from Alzheimer related treatments from those patients who will not, as proven by measuring to what extent the PET scans actually lead to earlier appropriate therapy, and in fact result in improved outcomes for Medicare beneficiaries and for the health care system in which they obtain care.

Conditions

Interventions

PROCEDURE

Amyloid imaging

Amyloid imaging brain scans are administered once to all arms.

PROCEDURE

FDG-PET

\[F-18\] FDG-PET brain scans are administered once to all arms.

Sponsors & Collaborators

Principal Investigators

  • Daniel Silverman, MD, Ph.D. · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2022-10-31
Completion
2022-12-31
FDA Drug
Yes
FDA Device
Yes

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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 NCT02317250 on ClinicalTrials.gov