Alzheimer DiseasePhase 2PLEODIAL-INCT02361424
Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD)
A Phase 2 study testing PXT00864 in people with Alzheimer Disease, run by Pharnext S.C.A. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- PXT00864
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Single-blind Sequential Placebo-controlled Prospective Phase IIA Pilot Study Assessing the Effects of PXT00864 in Mild AD Patients
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
- Being tested
- PXT00864, placebo
- Keywords
- PXT00864, mild AD, phase 2a
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXT00864Drug
PXT00864 is a fixed-dose combination of baclofen and acamprosate
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)
Number of Treatment Emergent Adverse Events (TEAEs)
Measured: throughout the 12-week study period.
Secondary outcomes (10)
Change From Baseline in the score of the Digit Symbol Substitution Test (DSST)
Scores on the DSST range from 0-93 with lower scores indicating greater impairment.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 B
Measured: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)
Change From Baseline in the score of the Free and Cued Selective Reminding Test (FCSRT)
FCSRT is a memory test administered according to the procedure described by Gröber and Buschke modified with 16 verbal items.
Measured: 1 (baseline) and V4 (end of study, after 12 weeks of treatment)
Change From Baseline in the score of the 4-item Instrumental Activities of Daily Living scale (IADL-PAQUID)
The 4-item Instrumental Activities of Daily Living scale (IADL) concerns four routine daily functions (using transportation, managing finances, using the phone and managing medicines use). Scores on the IADL range from 4-15 with higher scores indicating greater impairment.
Measured: V0 (train), V1 (baseline), and every 4 weeks (V2, V3 and V4)
Change From Baseline in the score of the Clinical Dementia Rating (CDR) scale
The Sum of Boxes score of the CDR ranges from 0 to 18, with higher scores indicating greater impairment.
Measured: 1 (baseline) and V4 (end of study, after 12 weeks of treatment)
Change From Baseline in the score of the Apathy Inventory (AI) scale
Scores on the AI range from 0-12 with higher scores indicating greater impairment.
Measured: 1 (baseline) and V4 (end of study, after 12 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharnext S.C.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Ascopharm Groupe Novasco
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Orgogozo, MD, Principal investigator, Hospital Pellegrin, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361424
- Sponsor's protocol ID
- CLN-PXT00864-03
- Acronym
- PLEODIAL-I
- Status last verified
- Oct 2015
- First submitted
- 19 Dec 2014
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Single-blind Sequential Placebo-controlled Prospective Phase IIA Pilot Study Assessing the Effects of PXT00864 in Mild AD Patients
- ClinicalTrials.gov ID
- NCT02361424
- Acronym / sponsor ID
- PLEODIAL-I / CLN-PXT00864-03
- Conditions
- Alzheimer Disease
- Keywords
- PXT00864, mild AD, phase 2a
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Pharnext S.C.A.University, hospital or other
- Collaborators
- Ascopharm Groupe Novasco
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PXT00864 Dose 1 | Experimental | Drug: PXT008641 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. |
| PXT00864 Dose 2 | Experimental | Drug: PXT008641 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. |
| PXT00864 Dose 3 | Experimental | Drug: PXT008641 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. |
| Placebo of PXT00864 | Placebo comparator | Drug: placebo1 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PXT00864PXT00864 is a fixed-dose combination of baclofen and acamprosate | Drug | PXT00864 Dose 1, PXT00864 Dose 2, PXT00864 Dose 3 |
| placebo | Drug | Placebo of PXT00864 |
Primary outcome
Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
Time frame: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)
Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater cognitive impairment.
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: throughout the 12-week study period.
10 secondary outcomes
Change From Baseline in the score of the Digit Symbol Substitution Test (DSST)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 B
Time frame: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)
Change From Baseline in the score of the Free and Cued Selective Reminding Test (FCSRT)
Time frame: 1 (baseline) and V4 (end of study, after 12 weeks of treatment)
Change From Baseline in the score of the 4-item Instrumental Activities of Daily Living scale (IADL-PAQUID)
Time frame: V0 (train), V1 (baseline), and every 4 weeks (V2, V3 and V4)
Change From Baseline in the score of the Clinical Dementia Rating (CDR) scale
Time frame: 1 (baseline) and V4 (end of study, after 12 weeks of treatment)
Change From Baseline in the score of the Apathy Inventory (AI) scale
Time frame: 1 (baseline) and V4 (end of study, after 12 weeks of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc Orgogozo, MD principal investigator
Hospital Pellegrin, Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PXT00864 in people with Alzheimer Disease, run by Pharnext S.C.A. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) (time frame: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.