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NCT06254469 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Alzheimer Disease and Chronic Traumatic Encephalopathy, sponsored by CereMark Pharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
- 1
- Study location
NCT06254469 is a Phase 3 study of Alzheimer Disease and Chronic Traumatic Encephalopathy that is actively recruiting participants, run by CereMark Pharma. The registered enrollment target is 230 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06254469, a Phase 3 study of Alzheimer Disease and Chronic Traumatic Encephalopathy, is actively recruiting participants, sponsored by CereMark Pharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG [F-18]Flornaptitril
Study Locations (1)
Illinois
- Endeavor Health Systems - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06254469
The ClinicalTrials.gov registry entry for NCT06254469 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (92% lower). The listed sponsor is CereMark Pharma, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which [F-18]Flornaptitril is the first listed.
NCT06254469 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT06254469 about?
NCT06254469 is a clinical study titled "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". 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). ...
What is the current status of trial NCT06254469?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2025-07-01. Estimated completion is 2029-06-30.
What conditions does trial NCT06254469 study?
This clinical trial studies the following conditions: Alzheimer Disease, Chronic Traumatic Encephalopathy.
What interventions are being tested in trial NCT06254469?
The interventions under investigation include: [F-18]Flornaptitril (DRUG).
Who is sponsoring clinical trial NCT06254469?
This trial is sponsored by CereMark Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06254469 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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