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

Pharnext S.C.A.

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: PXT00864

Study type: Interventional

Funder types: Other

Identifiers

NCT02361242

CLN-PXT00864-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

PXT00864 Dose 1

Experimental group

Description:

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.

Treatment:

Drug: PXT00864

PXT00864 Dose 2

Experimental group

Description:

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.

Treatment:

Drug: PXT00864

PXT00864 Dose 3

Experimental group

Description:

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.

Treatment:

Drug: PXT00864