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This is an open-label, 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin.
Following a screening of up to 28 days, eligible participants will be initially randomised to one of 2 arms (Arm 1 or Arm 2). Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Days 1-3: 5 g BID 4-6: 10 g BID 7-9: 15 g BID 10-21: 20 g BID |
|
| Arm 2 | Experimental | Days 1-3: 10 g BID 4-6: 10 g BID 7-9: 10 g BID 10-21: 20 g BID |
|
| Arm 3 | Experimental | Days 1-3: 15 g TID 4-6: 10 g TID 7-9: 10 g TID 10-21: 15 g TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-OLE-01-VA | Drug | formulation of tricaprilin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratings of discomfort of the adverse events nausea, dyspepsia, abdominal pain, abdominal distension, diarrhoea | Discomfort rating from 0 (no discomfort) to 4 (severe discomfort) | 21 days |
| Incidence of adverse events | Adverse event incidence will be tabulated Adverse event incidence will be tabulated Adverse event incidence will be tabulated | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Newstead | Queensland | 4006 | Australia |
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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 |