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

NCT02361242 | Completed Phase 2 DMC

• 1 other identifier: CLN-PXT00864-04
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

PXT00864; mild AD; phase 2a

Outcome Measures

Primary Outcomes (2)

• 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

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

• Number of Treatment Emergent Adverse Events (TEAEs)

  throughout the 24-week study period

Study Arms (3)

PXT00864 Dose 1

EXPERIMENTAL

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.

Drug: PXT00864

PXT00864 Dose 2

EXPERIMENTAL

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.

Drug: PXT00864

PXT00864 Dose 3

EXPERIMENTAL

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.

Drug: PXT00864

Interventions

PXT00864 DRUG

PXT00864 is a fixed-dose combination of baclofen and acamprosate

PXT00864 Dose 1; PXT00864 Dose 2; PXT00864 Dose 3

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild Alzheimer's Disease patient who was included in PLEODIAL-I study
• Mini Mental State Examination (MMSE) score greater or equal to 20

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharnext S.C.A.: lead
• Ascopharm Groupe Novasco: collaborator

Study Sites (1)

CMRR

Bordeaux, France, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jean-Marc Orgogozo, MD

  Hospital Pellegrin, Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 15, 2016

Record last verified: 2014-12

Locations

FR (1)