A Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease

  • STATUS
    Not Recruiting
  • participants needed
    81
  • sponsor
    Regenera Pharma Ltd
Updated on 27 January 2022
Investigator
Natalie L Pummill, B.A.
Primary Contact
Kawartha Centre - Redefining Healthy Aging (0.2 mi away) Contact
+4 other location

Summary

This study is a randomized, double-blind, placebo-controlled, multicentre, Phase 2 study, with an optional open-label extension, to evaluate the safety, tolerability, and efficacy of RPh201 in subjects with mild to moderate AD who are eligible for enrollment in this study.

Subject participation will include a Screening Phase, Treatment Phase, and an Optional Open-Label Extension. The Screening Phase will be up to 4 weeks prior to randomization. Both the subject and their study partner(s) will sign an informed consent form (ICF). At Visit 2, Subjects will be randomized 2:1 to RPh201 or placebo. The Treatment Phase will last for 6 months post-randomization, or until subject withdrawal from the study, whichever comes first. The Optional Open-Label Extension will begin once a subject has completed the Treatment Phase and the subject and their study partner(s) have signed an ICF to continue on the study. The Optional Open-Label Extension will continue for 6 months, or until subject withdrawal from the study, whichever comes first. Subjects who do not participate in the Optional Open-Label Extension will be asked to return for an optional post-study visit 6 months after the end of the Treatment Phase.

Subjects may participate in an optional biomarker sub-study. Up to 15 subjects may also participate in an optional FDG-PET sub-study during their study participation. Separate informed consent will be required for both of these sub-studies.

Details
Condition Mild to Moderate Dementia Due to Alzheimer's Disease, With or Without Coexisting Cerebrovascular Disease
Treatment Placebo, RPh201
Clinical Study IdentifierNCT03462121
SponsorRegenera Pharma Ltd
Last Modified on27 January 2022

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