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

Alzheimer Disease Clinical Trial

Official 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

Status Terminated

Clinical Trial 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

Clinical Trial Description

REM0046127 is a small molecule intended for the oral treatment of subjects suffering from Alzheimer's disease (AD). The pharmacological mechanism of REM0046127 is based on modulating Orai calcium (Ca2+) channel activity to normalize neuronal Ca2+ homeostasis in ADdiseased neurons. This mechanism is central in the AD-disease cascade and is therefore expected to modulate fast-acting mechanisms like restoration of impaired synaptic function, neuronal network activity (EEG), secretion of tau into CSF and synaptic CSF biomarkers to improve cognition (symptomatic). It is also expected to influence processes with slower kinetics like brain amyloid plaques formation and neuronal cell death to slow or even stop disease progression over time (neuroprotection). ;

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT05478031
• Study type: Interventional
• Source: reMYND
• Status: Terminated
• Phase: Phase 2
• Start date: June 7, 2022
• Completion date: June 4, 2024