REMAD-02; v4.0
Research type
Research Study
Full title
A randomized, placebo-controlled, double-blind, parallel-group Phase 2a exploratory study with placebo run-in to investigate PK/PD effects, safety, tolerability and pharmacokinetics of REM0046127 oral suspension compared with placebo in subjects with mild to moderate Alzheimer's disease
IRAS ID
1007402
Contact name
Koen De Witte
Contact email
Sponsor organisation
reMYND N.V.
Eudract number
2022-000080-43
Clinicaltrials.gov Identifier
Research summary
Alzheimer’s Disease (AD) is a neurodegenerative disease that affects 35 million people worldwide. Currently available treatments for AD have only modest effects on the symptoms of the disease and do not prevent disease progression.
In AD diseased neurons, the levels of calcium in the cytosol of the cell are abnormally elevated which cause dysfunction in synapses, AD pathology and cell death in the brain. REM0046127 is a small molecule that decreases levels of cytosolic calcium in AD diseased neurons. This mechanism is expected to modulate neuronal activity in the brain (electroencephalogram [EEG]), and cerebrospinal fluid (CSF) markers of disease to improve thinking and memory. It is also expected to reduce formation of brain amyloid plaques and cell death to slow or stop disease progression.
The purpose of REMAD-02 is to measure effects of an oral drug called REM0046127 on CSF disease markers, electroencephalogram (EEG) and safety compared with placebo in subjects with mild to moderate AD.
The study will include 6 subjects between age 50 and 85 (inclusive).
Subjects will visit the research unit every week.
After an initial 14 day placebo run-in period, subjects will be randomised (1:1:1 allocation) to one of three conditions for 28 days: 1400mg dose, a 350mg dose or placebo for 28 days. There is then a 7 day follow-up period.
The trial will take place in one site in the UK. The trial is sponsored by reMYND.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0179
Date of REC Opinion
29 Jan 2025
REC opinion
Further Information Unfavourable Opinion