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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PXT00864 Dose 1

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.

Group Type EXPERIMENTAL

PXT00864

Intervention Type DRUG

PXT00864 is a fixed-dose combination of baclofen and acamprosate

PXT00864 Dose 2

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.

Group Type EXPERIMENTAL

PXT00864

Intervention Type DRUG

PXT00864 is a fixed-dose combination of baclofen and acamprosate

PXT00864 Dose 3

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.

Group Type EXPERIMENTAL

PXT00864

Intervention Type DRUG

PXT00864 is a fixed-dose combination of baclofen and acamprosate

Interventions

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PXT00864

PXT00864 is a fixed-dose combination of baclofen and acamprosate

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No