Mild to Moderate Dementia Due to Alzheimer's Disease Clinical Trial
Official title:
A 6-Month, Double-Blind, Phase 2 Study and 6-Month Open- Label Extension Evaluating the Safety, Tolerability, and Clinical Benefit of RPh201 in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease
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.
n/a