Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial
Stopped early
Conditions studied: Mild Cognitive Impairment, Dementia, Alzheimer's Disease
In brief
The main purpose of this study is to build upon the evidence captured in the Imaging Dementia - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable information regarding patient-reported outcomes and physician confidence in diagnosis and management based on the Implications for Management of PET Amyloid Classification Technology (IMPACT; NCT number not yet assigned) trial design.
Key facts
- Study ID
- NCT02781220
- Run by
- University of Utah
- People needed
- 69
- Starts
- 2016-07-01
- Expected to finish
- 2023-06-10
- Last updated by the study team
- 2024-12-09
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 65 and older;
- Medicare beneficiary;
- Diagnosis of mild cognitive impairment (MCI) or dementia, according to Diagnostic and Statistical Manual - IV (DSM-IV) and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011);
- Meets AUC:
- Cognitive complaint verified by objectively confirmed cognitive impairment;
- The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging as below;
- Alzheimer's disease is a diagnostic consideration;
- Knowledge of amyloid PET status is expected to alter diagnosis and management.
- Head MRI and/or CT within 24 months prior to enrollment;
- Clinical laboratory assessment within the 12 months prior to enrollment: complete blood count (CBC), standard blood chemistry profile, thyroid stimulating hormone (TSH); vitamin B12;
- Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
- English or Spanish speaking (for the purposes of informed consent);
- Willing and able to provide consent. Consent may be by proxy.
You may not qualify if…
- Normal cognition or subjective complaints that are not verified by cognitive testing.
- Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
- Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E, or in lieu of genotyping for suspected autosomal mutation carriers.
- Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).
- Cancer requiring active therapy (excluding non-melanoma skin cancer);
- Hip/pelvic fracture within the 12 months prior to enrollment;
- Body weight exceeds PET scanner weight limit;
- Life expectancy less than 24 months based on medical co-morbidities;
- Residence in a skilled nursing facility.
Where it is running
- Center for Alzheimer's Care, Imaging & Research — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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