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

Pharnext S.C.A.45 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

PXT00864DRUG

PXT00864 is a fixed-dose combination of baclofen and acamprosate

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

CMRR

Bordeaux, France, France

Outcomes

Primary Outcomes

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

Time frame: V5 (study entry), V6 (after 12 weeks), V7 (after 24 weeks)

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame: throughout the 24-week study period

Data from ClinicalTrials.gov

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