A Phase 2a Study to Investigate REM0046127 in Mild to Moderate Alzheimer's Disease (NCT05478031) | Clinical Trial Compass
TerminatedPhase 2
A Phase 2a Study to Investigate REM0046127 in Mild to Moderate Alzheimer's Disease
Stopped: Due to the event of repeated elevated transaminase levels in one subject - elevated ALT/AST up to 6x ULN in the absence of any other potential underlying cause - we have decided to terminate the study.
The purpose of this study is to measure effects on CSF biomarkers, EEG and safety with REM0046127 oral suspension compared with placebo in subjects with mild to moderate Alzheimer disease.
* The study duration will be up to 2 months for each treated subject
* Each subject will start with a 14-day placebo run-in period, followed by a 28-day treatment period and 7-day follow-up period
* Visit frequency: every week
* Number of Subjects: at least 30 subjects with an upper limit of 60 subjects.
* Study Arms and Duration: All subjects will be randomized (1:1:1 allocation) to one ofthree different starting levels after the 14-day run-in period:
* REM0046127 high dose: 1400mg (700mg bid) oral suspension per day for 28 days
* REM0046127 low dose: 350mg (175mg bid) oral suspension per day for 28 days
* Placebo: placebo oral suspension bid for 28 days
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Mild to moderate AD as characterized by the following clinical, cognitive, and functional criteria.
. Biomarker profile reflecting AD, according to The National Institute on Aging- Alzheimer's Association (NIA-AA) Research Framework based on Screening CSF Aβ1-42 and p-tau concentrations
. Clear EEG deficit as assessed by the EEG reader
. MMSE score above 12 (preferably above 16) and a maximum of 24
. A brain imaging study, such as magnetic resonance imaging (MRI) and/or computed tomography (CT) scan having been performed within last 6 months from day of the Screening visit or during the Screening phase of this study consistent with the clinical diagnosis of AD and excluding other potential causes of dementia. If there has been a significant change in clinical status suggestive of stroke or other possible central neurological disease with onset between the time of the last MRI or CT and the Screening evaluation, an MRI scan should be repeated during Screening procedures if considered appropriate by the Investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events
Timeframe: From first dosing to 7 days after last dose as follow-up. 14 days Run-in + 28 days treament + 7 days Follow-up
. If taking an approved cholinesterase inhibitor or NMDA antagonist for treatment of Alzheimer's disease, treated with a stable dose for at least 6 months prior to the screening visit and the dose is not expected to change during the study as per investigators judgement, or must be off such Alzheimer medication for a period of 8 weeks prior to screening
. Willing and able to give informed consent.
. Have a caregiver who assists the participant every day and has intimate knowledge of the participant's cognitive, functional, and emotional states and of the participant's personal care. The caregiver must be willing to accompany the participant to all study visits and to supervise IMP administration as well as report adverse events. The caregiver must be willing and able to give informed consent for their own participation and be able to read and write.
. Be able to read, write, speak clearly for the cognitive tests, with eyesight and hearingsufficient to enable completion of the cognitive tests
. COVID-19 positive test at the screening visit
. Clinical, laboratory or neuro-imaging findings consistent with:
. Current presence of a clinically significant major psychiatric disorder according to the criteria of the DSM-IV, or symptom that could affect the subject's ability to complete the study
. Current clinically significant systemic illness, e.g., neoplasia, that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study