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| Name | Class |
|---|---|
| Ascopharm Groupe Novasco | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXT00864 | Drug | PXT00864 is a fixed-dose combination of baclofen and acamprosate |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc Orgogozo, MD | Hospital Pellegrin, Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMRR | Bordeaux | France | France |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |