NCT01969123

A Randomized, Double-blind, Placebo-controlled, Parallel-Group, 26-Week, Phase 3 Study of 2 Doses of EVP-6124 or Placebo in Subjects With Mild to Moderate Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

Terminated Phase 3 Last updated 2 May 2016

What this trial tests

Phase 3 trial testing Drug: EVP-6124 in Alzheimer's Disease in 474 participants. Terminated before completion.

Timeline

1 October 2013

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	FORUM Pharmaceuticals Inc
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	474
Start date	1 October 2013
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	82 locations across United States, Australia, Belgium, Canada, France, Germany, Italy, Mexico

Drugs / interventions tested

• Drug: EVP-6124 — full drug profile →
• Placebo

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →
• Dementia — all drugs for Dementia →

Sponsor

FORUM Pharmaceuticals Inc — full company profile →

Who can join

Adults 55 to 85, any sex, with Alzheimer's Disease or Dementia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 13-item (ADAS-Cog-13) to Day 182
  Time frame: Baseline to Day 182 or Early Termination
• Change from Baseline in the Clinical Dementia Rating Sum of the Boxes (CDR-SB) to Day 182
  Time frame: Baseline to Day 182 or Early Termination
• Safety and tolerability of EVP-6124 or Placebo in Subjects with AD
  Time frame: Baseline to Day 182 or ET
  All adverse experiences spontaneously reported by subject and/or observed by an investigator and repeated clinical evaluation of physical exam, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG and laboratory tests (hematology/blood chemistry/urinalysis)

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical trials of new drugs for Alzheimer disease.
   Huang LK, Chao SP, Hu CJ. · · 2020 · cited 426× · PMID 31906949 · DOI 10.1186/s12929-019-0609-7
2. Drug candidates in clinical trials for Alzheimer's disease.
   Hung SY, Fu WM. · · 2017 · cited 281× · PMID 28720101 · DOI 10.1186/s12929-017-0355-7
3. A phase 2 randomized, controlled trial of the α7 agonist ABT-126 in mild-to-moderate Alzheimer's dementia.
   Gault LM, Ritchie CW, Robieson WZ, Pritchett Y, et al · · 2015 · cited 34× · PMID 29854928 · DOI 10.1016/j.trci.2015.06.001
4. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension.
   Gault LM, Lenz RA, Ritchie CW, Meier A, et al · · 2016 · cited 33× · PMID 27756421 · DOI 10.1186/s13195-016-0210-1
5. Galantamine Inhibits Aβ_1-42-Induced Neurotoxicity by Enhancing α7nAChR Expression as a Cargo Carrier for LC3 Binding and Aβ_1-42 Engulfment During Autophagic Degradation.
   Lin MW, Chen YH, Yang HB, Lin CC, et al · · 2020 · cited 15× · PMID 31823156 · DOI 10.1007/s13311-019-00803-7
6. A Systematic Review on Drugs Acting as Nicotinic Acetylcholine Receptor Agonists in the Treatment of Dementia.
   Crestini A, Carbone E, Rivabene R, Ancidoni A, et al · · 2024 · cited 11× · PMID 38334629 · DOI 10.3390/cells13030237
7. Human restricted <i>CHRFAM7A</i> gene increases brain efficiency.
   Jakimovski D, Dorn RP, Regno MD, Bartnik A, et al · · 2024 · cited 1× · PMID 38711941 · DOI 10.3389/fnins.2024.1359028