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

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: PXT00864

• Registration Number: NCT02361242
• Lead Sponsor: Pharnext S.C.A.

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2014-12
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2016-02-12
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PXT00864 Dose 1	PXT00864	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.
PXT00864 Dose 2	PXT00864	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.
PXT00864 Dose 3	PXT00864	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

CMRR; 🇫🇷 Bordeaux, France