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Be Part of Research - Trial Details - Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease

Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease

Completed

Open to: ALL

Age: 55.0 - 85.0

Medical Conditions

Alzheimer Disease


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24 weeks in subjects with mild Alzheimer's disease. The primary objective is to demonstrate significant improvement relative to placebo-treatment in episodic memory function, as assessed by the Hopkins Verbal Learning Test. Secondary endpoints include Clinical Dementia Rating scale (CDR), Wechsler Memory Scale (WMS), Mini-Mental-Status-Examination (MMSE) and Cerebrospinal fluid (CSF) biomarkers of AD disease activity and progression.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2017 Jun 2019

Publications

"Prins ND, Harrison JE, Chu HM, Blackburn K, Alam JJ, Scheltens P; REVERSE-SD Study Investigators. A phase 2 double-blind placebo-controlled 24-week treatment clinical study of the p38 alpha kinase inhibitor neflamapimod in mild Alzheimer's disease. Alzheimers Res Ther. 2021 May 27;13(1):106. doi: 10.1186/s13195-021-00843-2."; "34044875"; "Tormahlen NM, Martorelli M, Kuhn A, Maier F, Guezguez J, Burnet M, Albrecht W, Laufer SA, Koch P. Design and Synthesis of Highly Selective Brain Penetrant p38alpha Mitogen-Activated Protein Kinase Inhibitors. J Med Chem. 2022 Jan 27;65(2):1225-1242. doi: 10.1021/acs.jmedchem.0c01773. Epub 2021 May 11."; "33974419"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 40 mg neflamapimod capsule

Intervention Arm Group : neflamapimod;

Intervention Type : OTHER
Intervention Description : matching placebo capsule

Intervention Arm Group : placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Fulbourn Hospital
    Cambridge
    CB21 5EF
  • MAC Clinical Research Tankersley
    Barnsley
    S75 3DL
  • Re:Cognition Health Birmingham
    Birmingham
    B16 8LT
  • MAC Clinical Research Blackpool
    Blackpool
    FY2 0JH
  • MAC Clinical Research Leeds
    Leeds
    LS10 1DU
  • MAC Clinical Research Liverpool
    Liverpool
    L34 1BH
  • Re:Cognition Health London
    London
    W1G 9JF
  • St. Pancras Clinical Research
    London
    WC1X 8QD
  • MAC Clinical Research Manchester
    Manchester
    M13 9NQ
  • Re:Cognition Health Plymouth
    Plymouth
    PL5 8BT
  • 5 Boroughs/North West Boroughs Healthcare NHS Foundation Trust
    Warrington
    WA22 8WA


The study is sponsored by EIP Pharma Inc and is in collaboration with Worldwide Clinical Trials; Amsterdam UMC, location VUmc.




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Read full details for Trial ID: NCT03402659
Last updated 28 September 2021

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