Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD)

NCT02361424 | Completed Phase 2 DMC

• 1 other identifier: CLN-PXT00864-03
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy on cognitive impairment and functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen at low dose) in patients with mild Alzheimer Disease.

Conditions

Alzheimer Disease

Keywords

PXT00864; mild AD; phase 2a

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

  Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater cognitive impairment.

  Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

• Number of Treatment Emergent Adverse Events (TEAEs)

  throughout the 12-week study period.

Secondary Outcomes (10)

• Change From Baseline in the score of the Digit Symbol Substitution Test (DSST)

  Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

• Change From Baseline in the speed to perform the Zazzo's Cancellation Test

  Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

• Change From Baseline in the score of the Zazzo's Cancellation Test

  Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

• Change From Baseline in the score of the 15-second Isaacs Set Test

  Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

• Change From Baseline in the time score of the Trail Making Test - part A

  Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

Other Outcomes (1)

• Change From Baseline in the cognitive Event Related Potential parameters (optional)

  V1 (baseline), and every 4 weeks (V2, V3 and V4)

Study Arms (4)

PXT00864 Dose 1

EXPERIMENTAL

1 orange capsule containing 0.4 mg of acamprosate , and 1 white capsule containing 6 mg of baclofen These 2 capsules are taken orally b.i.d. during 8 weeks.

Drug: PXT00864

PXT00864 Dose 2

EXPERIMENTAL

1 orange capsule containing 1 mg of acamprosate , and 1 white capsule containing 15 mg of baclofen . These 2 capsules are taken orally b.i.d. during 8 weeks.

Drug: PXT00864

PXT00864 Dose 3

EXPERIMENTAL

1 orange capsule containing 20 mg of acamprosate , and 1 white capsule containing 12 mg of baclofen . These 2 capsules are taken orally b.i.d. during 8 weeks.

Drug: PXT00864

Placebo of PXT00864

PLACEBO COMPARATOR

1 orange capsule containing placebo of acamprosate , and 1 white capsule containing placebo of baclofen . These 2 capsules are taken orally b.i.d. during 4 weeks

Drug: placebo

Interventions

PXT00864 DRUG

PXT00864 is a fixed-dose combination of baclofen and acamprosate

PXT00864 Dose 1; PXT00864 Dose 2; PXT00864 Dose 3

placebo DRUG

Placebo of PXT00864

Eligibility Criteria

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

You may qualify if:

• Male or female patients aged ≥ 60 years.
• Patient with a diagnosis of probable AD
• Progressive decline in cognition for more than six months which story is documented in patient medical records
• A Mini-Mental State Examination (MMSE) score of 20-26
• With a minimum of educational background
• Naïve to anti-dementia treatment
• MRI assessment which corroborates the clinical diagnosis (hippocampal atrophy) and excludes other potential causes of dementia especially cerebrovascular lesions
• If available, Cerebral Spinal Fluid (CSF) classical biomarkers should be at levels which corroborate the clinical diagnosis
• Ambulatory patient living at home with a caregiver available and living in the same household or interacting with the patient daily and available if necessary to ensure administration of the investigational product
• Absence of major or severe depressive disease
• Patient with a willingness to participate in this study and who have signed an informed consent form

You may not qualify if:

• Early onset of dementia, i.e. before 60 years old to avoid hereditary AD forms
• Significant neurological disease other than AD
• Major psychiatric disorder or syndrome (schizophrenia or bipolar disorder)
• Seizure disorders
• Other infectious, metabolic or systemic diseases affecting central nervous system
• Other active clinically significant illness
• Hospitalization or change of chronic concomitant medications one month prior to screening
• Patients with severe respiratory, hepatic or renal failure or with any other significantly potentially disabling abnormality detected during screening
• Known hypersensitivity to the tested treatment including active substance and excipients.
• Patients participating in another study and exposed to any investigational therapy within the 30 days prior to the entry in this study.
• Patient without medical care insurance

Sponsors & Collaborators

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

Study Sites (1)

CMRR

Bordeaux, 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: February 11, 2015
• Study Start: February 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 15, 2016

Record last verified: 2015-10

Locations

FR (1)