Start: February 2016
End: December 2017
What Is This Study About?
This study will assess the impact of amyloid positron emission tomography (PET) imaging on outcomes in patients with mild cognitive impairment or dementia of uncertain origin. Researchers seek to demonstrate that amyloid PET can help clinicians diagnose the cause of cognitive impairment, provide the most appropriate treatments and recommendations, and improve health outcomes.
Do I Qualify To Participate in This Study?
- Medicare beneficiary
- Diagnosis of MCI or dementia
- Cognitive complaint verified by objectively confirmed cognitive impairment
- Cause of cognitive impairment is uncertain after comprehensive evaluation by dementia specialist, including general medical and neurological examination, mental status testing, laboratory testing, and structural neuroimaging
- 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 (complete blood count, standard blood chemistry profile, thyroid stimulating hormone, vitamin B12) within 12 months prior to enrollment
- Able to tolerate amyloid PET imaging
- English or Spanish speaking
- Willing and able to provide consent; consent may be by proxy
Must NOT have:
- Normal cognition or subjective complaints that are not verified by cognitive testing
- Knowledge of amyloid status that, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact patient or family
- Scan ordered solely based on family history of dementia, presence of apolipoprotein E, or in lieu of genotyping for suspected autosomal mutation carriers
- Scan ordered for nonmedical purposes, such as legal, insurance coverage, or employment screening
- Cancer requiring active therapy (excluding non-melanoma skin cancer)
- Hip/pelvic fracture within 12 months prior to enrollment
- Body weight exceeds PET scanner weight limit
- Life expectancy of less than 24 months based on medical co-morbidities
- Residence in a skilled nursing facility
Who Is the General Study Contact?
For more information about this study and a list of study locations, visit www.ideas-study.org.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Lead: American College of Radiology Imaging Network
Source: ClinicalTrials.gov ID: NCT02420756