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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02361242

Acronym

PLEODIAL-II

Enrollment

Registered

2015-02-11

Start date

2013-06-30

Completion date

2015-12-31

Last updated

2016-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

PXT00864, mild AD, phase 2a

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.

Interventions

DRUGPXT00864

PXT00864 is a fixed-dose combination of baclofen and acamprosate

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026