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The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, global function, activities of daily living, resource utilisation, safety, and tolerability, in participants with mild to moderate AD dementia.
This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tricaprilin | Active Comparator | Tricaprilin formulation twice daily for 26 weeks, liquid for oral administration |
|
| Placebo | Placebo Comparator | Placebo formulation, twice daily for 26 weeks, liquid for oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricaprilin | Drug | Each dose of IMP will be administered orally 30 minutes after completing a full meal. There is 1 g of tricaprilin per 2 ml of AC-OLE-01-VA. Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of tricaprilin; 80 ml total daily dose of AC-OLE-01-VA, over the course of 2-4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score | The ADAS-Cog is a cognitive scale that assesses memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment). | 26 weeks |
| Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) | The ADCS-CGIC is a clinician-rated scale of cognition, function, and behavior. Scores range from 1 (marked improvement) to 7 (marked worsening). | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in a composite score of Category Fluency Test (CFT), Controlled Oral Word Association Test (COWAT), and ADAS-Cog subtests Word Recall, Word Recognition and Orientation | The CFT is a cognitive test assessing a participant's semantic fluency, a measure of executive function. Participants are given 60 seconds to name as many examples of a category, with 1 point for each correct, unique response given. The COWAT is a cognitive test assessing a participant's phonemic fluency, a measure of executive function. Participants are given 60 seconds (per word) to say as many words as possible beginning e.g., with the letters F, A and S (in English, equivalents will be used for other languages), with 1 point for each original and correct word. The ADAS-Cog is a cognitive scale that assesses memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment). |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Biomarker Analysis |
| 26 weeks |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 6568132999 | clinical@cerecin.com |
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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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| ID | Term |
|---|---|
| C003637 | tricaprylin |
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|
| Placebo | Drug | Each dose of IMP will be administered orally 30 minutes after completing a full meal. Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of placebo; 80 ml total daily dose of placebo, over the course of 2-4 weeks. |
|
| 26 weeks |
| Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score | The ADCS-ADL is a 23-item semi-structured interview with a caregiver and assesses 6 basic activities of daily living and 7 instrumental activities of daily living with a total score of 0 to 78. Lower scores indicate greater severity. | 26 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |