24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I Completion

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients having completed the previous 12-week PLEODIAL-I study were eligible to receive PXT00864 in this 24-week open-label extension PLEODIAL-II study in order to collect some additional long-term data regarding the safety and the potential effect of PXT00864 on cognitive and behavioural impairments.

Official Title
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24-week Open-label Extension Study Evaluating the Effect of PXT00864 in Mild Alzheimer's Disease Patients Further to PLEODIAL-I Completion

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: PXT00864


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Mild Alzheimer's Disease patient who was included in PLEODIAL-I study Mini Mental State Examination (MMSE) score greater or equal to 20 Main Exclusion Criteria: Patient who was not compliant with the previous PLEODIAL-I study protocol Patient who experienced significant adverse events which necessitated treatment discontinuation during the PLEODIAL-I study

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PXT00864 Dose 1<br>1 orange capsule containing 0.4 mg of acamprosate and 1 white capsule containing 6 mg of baclofen are taken orally b.i.d during 24 weeks. | Drug: PXT00864<br>* PXT00864 is a fixed-dose combination of baclofen and acamprosate<br>|
| Experimental: PXT00864 Dose 2<br>1 orange capsule containing 1 mg of acamprosate and 1 white capsule containing 15 mg of baclofen are taken orally b.i.d during 24 weeks. | Drug: PXT00864<br>* PXT00864 is a fixed-dose combination of baclofen and acamprosate<br>|
| Experimental: PXT00864 Dose 3<br>1 orange capsule containing 20 mg of acamprosate and 1 white capsule containing 12 mg of baclofen are taken orally b.i.d during 24 weeks. | Drug: PXT00864<br>* PXT00864 is a fixed-dose combination of baclofen and acamprosate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the total score of the 11-items Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | Scores on the ADAS-Cog range from 0 to 70 with higher scores indicating greater cognitive impairment | V5 (study entry), V6 (after 12 weeks), V7 (after 24 weeks) | 
| Number of Treatment Emergent Adverse Events (TEAEs) |  | throughout the 24-week study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PXT00864, mild AD, phase 2a