CMK-0301 is a multi-site, randomized clinical trial to evaluate the safety and efficacy of \[F-18\]Flornaptitril-PET (F-18 FNT-PET) for the prediction of clinical progression of Mild Cognitive Impairment (MCI) with either Suspected Chronic Traumatic Encephalopathy (CTE) or Alzheimer's Disease (AD). The primary objectives of the study are to: (1) To determine the accuracy of F-18 FNT-PET in prediction of clinical decline and (2) To assess the safety and tolerability of F-18 FNT. The secondary objectives include: (1) To demonstrate the feasibility of F-18 FNT-PET in differentiation of participants with suspected chronic traumatic encephalopathy (CTE) from those with suspected Alzheimer's disease (AD) by trained image readers, (2) To evaluate disease progression in participants with suspected CTE or AD and (3) To evaluate the correlation between F-18 FNT-PET regional and summary visual reads scan and other assessments.
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Accuracy of F-18 FNT-PET in prediction of clinical decline
Timeframe: 2 years
Assessment of the safety of F-18 FNT using adverse events and serious adverse events.
Timeframe: 2 years
Assessment of the safety of F-18 FNT using vital signs.
Timeframe: 2 years
Assessment of the safety of F-18 FNT using clinical laboratory assessments.
Timeframe: 2 years
Assessment of the safety of F-18 FNT using electrocardiograms
Timeframe: 2 years
Assessment of the safety of F-18 FNT using the Suicide Behavior Questionnaire-Revised
Timeframe: 2 years