24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I Completion
NCT02361242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2016-02-15
Summary
PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03 protocol) and is designed for the descriptive analysis of patients with mild AD who are exposed to PXT00864 over an additional 24-week period.
Conditions
- Alzheimer Disease
Interventions
- DRUG
-
PXT00864
PXT00864 is a fixed-dose combination of baclofen and acamprosate
Sponsors & Collaborators
-
Ascopharm Groupe Novasco
collaborator OTHER -
Pharnext S.C.A.
lead OTHER
Principal Investigators
-
Jean-Marc Orgogozo, MD · Hospital Pellegrin, Bordeaux, France
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- France
Study Locations
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