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NCT01969136

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 403 participants. Terminated before completion.

Timeline
1 October 2013
Primary endpoint
1 January 2017
1 January 2017

Quick facts

Lead sponsorFORUM Pharmaceuticals Inc
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment403
Start date1 October 2013
Primary completion1 January 2017
Estimated completion1 January 2017
Sites81 locations across United States, Argentina, Australia, Canada, Czechia, France, Germany, Italy

Drugs / interventions tested

Conditions studied

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.

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

8 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. Neuroprotective Effects of Cholinesterase Inhibitors: Current Scenario in Therapies for Alzheimer's Disease and Future Perspectives.
    Moreira NCDS, Lima JEBF, Marchiori MF, Carvalho I, et al · · 2022 · cited 59× · PMID 35591949 · DOI 10.3233/adr-210061
  4. 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
  5. 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
  6. Galantamine Inhibits Aβ<sub>1-42</sub>-Induced Neurotoxicity by Enhancing α7nAChR Expression as a Cargo Carrier for LC3 Binding and Aβ<sub>1-42</sub> 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
  7. 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
  8. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment.
    Lim AWY, Schneider L, Loy C. · · 2024 · cited 8× · PMID 39498781 · DOI 10.1002/14651858.cd001747.pub4

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