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A Phase 2a Study to Investigate REM0046127 in Mild to Moderate Alzheimer's Disease

NCT05478031 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-03

No results posted yet for this study

Summary

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

Conditions

  • Alzheimer Disease

Interventions

DRUG

REM0046127 High Dose

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. REM0046127 high dose: 1400mg (700mg bid) oral suspension per day for 28 days

DRUG

REM0046127 Low Dose

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. REM0046127 low dose: 350mg (175mg bid) oral suspension per day for 28 days

DRUG

Placebo

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. Placebo: placebo oral suspension bid for 28 days and during the 14-days run-in phase

Sponsors & Collaborators

  • reMYND

    lead INDUSTRY

Principal Investigators

  • Jort Vijverberg, MD · BRC Amsterdam

  • Koen De Witte, PhD · CEO of reMYND

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2024-06-04
Completion
2024-06-04

Countries

  • Netherlands
  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05478031 on ClinicalTrials.gov