Visualizing Brain Proteinopathies Using [F-18]Flornaptitril-PET in the Prediction of Clinical Progression of Mild Cognitive Impairment With Either Suspected Chronic Traumatic Encephalopathy or Alzheimer's Disease

Part of paid clinical trials in Evanston, Illinois.

Sponsor
CereMark Pharma, LLC
Study ID
NCT06254469
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • [F-18]Flornaptitril — DRUG
    All participants will receive a single dose of F-18 FNT during an imaging visit.

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: Part A - Lead in
    Part A plans to enroll 50 participants (approximately 20 participants with mild cognitive impairment \[MCI\] due to suspected CTE, 20 participants with MCI due to suspected AD, and 10 age-matched healthy volunteers, whose age is within 3 years of any participants with MCI due to suspected CTE or AD in Part A).
  • Experimental: Part B - AD
    Part B plans to enroll 90 participants with MCI due to suspected AD for primary accuracy assessments of F-18 FNT-PET imaging.
  • Experimental: Part B - CTE
    Part B plans to enroll 90 participants with MCI due to suspected CTE from concussive and percussive injuries in approximately 1:1 ratio for primary accuracy assessments of F-18 FNT-PET imaging.

Primary Outcome Measure

Accuracy of F-18 FNT-PET in prediction of clinical decline [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Endeavor Health SystemsEvanstonIllinois60201
Rosa M Vazquez
[email protected]
8475034333
Chad Yucus, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Evanston, IL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Endeavor Health Systems· Evanston, IL

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