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New treatment option for Alzheimer Disease
Official title 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
ClinicalTrials.gov ID: NCT06254469
What this study is testing
What is [F-18]Flornaptitril?
[F-18]Flornaptitril is an investigational medicine, being studied as a potential treatment for alzheimer disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older. Healthy volunteers may be eligible.
You may be able to join if
- Participants with MCI enrolling in the trial must meet all the following criteria: 1\. Diagnosis of MCI due to suspected CTE, and with age \>45...
- Diagnosis of MCI due to suspected AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's...
- Documented evidence of memory decline with gradual onset and slow progression for at least 1 year. If medically documented evidence is not available...
- An MMSE-2 score of 22 to 30, inclusive, at the Screening Visit
- Biomarker positive based on predefined plasma p-tau cutoff
You likely can't join if
- Pregnant or breastfeeding
- Unable to remain still for duration of imaging procedure or have an inability to tolerate neuropsychological, clinical, or PET scan studies (e.g...
- History of stroke, transient ischemic attack, seizures, or other condition of the head or neck within 12 months prior to the Screening Visit that, in...
- Preexisting major neurologic or other physical illness that could confound results (e.g., multiple sclerosis, diabetes, cancer)
- Psychiatric disorder such as mania, schizophrenia, anxiety, or depression (Geriatric Depression Scale ≥10), which in the Investigator's opinion...
- Condition or personal circumstance that, in the Investigator's opinion, might interfere with the collection of complete, good quality data
See the full eligibility criteria
- Participants with MCI enrolling in the trial must meet all the following criteria: 1\. Diagnosis of MCI due to suspected CTE, and with age \>45 years, or AD, and with age \>50 years at the time of the Screening Visit...
- Diagnosis of MCI due to suspected AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA)
- Documented evidence of memory decline with gradual onset and slow progression for at least 1 year. If medically documented evidence is not available, an informant may provide confirmatory evidence
- An MMSE-2 score of 22 to 30, inclusive, at the Screening Visit
- Biomarker positive based on predefined plasma p-tau cutoff
- Modified Hachinski Ischemic Score of ˂4 at the Screening Visit
- Cognitive deficits do not occur exclusively in the context of delirium
- Cognitive deficits are not better explained by another mental disorder (e.g., major depressive disorder, schizophrenia), or other medical condition (e.g., hypothyroidism)
- Treated with a stable dosage regimen of acetylcholinesterase inhibitors (AchEI) and/or memantine for at least 4 months prior to the Screening Visit. Participants should be expected to remain on a stable dosage regimen...
- Medically healthy, at the age within 3 years of any participants with MCI due to suspected CTE or AD in Part A, and with no clinically relevant findings on physical examination or laboratory results
- Participants must have a trial partner who has frequent interaction with them (approximately \>3-4 times per week), will be present for all clinic visits, and can assist in compliance with trial procedures
- No cognitive impairment based upon cognitive assessment and as evaluated by the Investigator
- No first-degree family history of early-onset AD or other neurodegenerative diseases (prior to age 65)
- An MMSE-2 score ≥27.
- Pregnant or breastfeeding
- Unable to remain still for duration of imaging procedure or have an inability to tolerate neuropsychological, clinical, or PET scan studies (e.g., head tremor that may cause head motion artifact, uncontrollable...
- History of stroke, transient ischemic attack, seizures, or other condition of the head or neck within 12 months prior to the Screening Visit that, in the Investigator's opinion, might affect circulation to the head or...
- Preexisting major neurologic or other physical illness that could confound results (e.g., multiple sclerosis, diabetes, cancer)
- Psychiatric disorder such as mania, schizophrenia, anxiety, or depression (Geriatric Depression Scale ≥10), which in the Investigator's opinion, might interfere with completing trial procedures
- Condition or personal circumstance that, in the Investigator's opinion, might interfere with the collection of complete, good quality data
- History of significant prescription drug, non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin, or derivatives
- Previously received F-18 FNT at any time, or any other investigational product (IP) within the past 30 days
- History of allergic reactions to albumin, or severe anemia or cardiac failure in which case the use of albumin would be medically contraindicated
- Unstable cardiac disease or uncontrolled hypertension (systolic blood pressure [BP] \>170 mmHg or diastolic BP \>100 mmHg)
- Any use of benzodiazepines within 24 hours prior to all trial visits
- Plan to take ibuprofen or naproxen within 5 days before the PET scan
- Received any radioactive drugs or scans within the previous month or 10 half-lives of the drug, whichever is longer, or participated in imaging or other clinical research studies that might confound trial results
- Implants (e.g., implanted cardiac pacemakers or defibrillators, insulin pumps, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips, or other medical implants that have not been certified for...
- History of any CT/MRI finding such as mass lesions or brain infection that are unrelated to the trial
- Participated in another clinical trial for an investigational agent (other than monoclonal antibody) and taken at least one dose of trial drug, unless confirmed as placebo, within 90 days prior to the Screening Visit...
- Monoclonal antibody treatment within the previous 180 days prior to the Screening Visit
- Plan to receive treatment of aducanumab, lecanemab, or other potentially approved treatment options for Early AD during the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Evanston, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Evanston, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.