Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01702480 | Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects | PHASE1 | COMPLETED | 116 | — | — | Nov 5, 2012 | Jul 3, 2015 | May 9, 2017 | 1 | United Kingdom |
To select the dose of GSK2981710 that achieves the best PK profile, the duration of maximum elevation of beta-hydroxybutrate (BHB) will be measured.
To select the dose of GSK2981710 that achieves the best PK profile the AUC of GSK2981710 will be measured.
To select the dose of GSK2981710 that achieves the best PK profile the Cmax of GSK2981710 will be measured.
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used. This test assesses visual memory and new learning
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses the participant's ability to recall as many of the words as possible immediately following the presentation of list of words.
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses the participant's ability to retain spatial information and to manipulate remembered items in working memory.
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses continuous performance and visual sustained attention.
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test measures of attention, and combines simple reaction time and choice reaction time elements
This test measures the participant's ability to recognize objects previously presented on a computer screen, and more importantly, to recall the spatial location of those objects.
| Arm | Type | Description |
|---|---|---|
| Part 1: GSK2981710 10 gram (g) | EXPERIMENTAL | Eight subjects will receive single dose of GSK2981710 in the form of 10 g medium-chain triglycerides (MCT) powder daily for 14 days. |
| Part 1: GSK2981710 20 g | EXPERIMENTAL | Eight subjects will receive single dose of GSK2981710 in the form of 20 g MCT powder daily for 14 days. |
| Part 1: GSK2981710 30 g | EXPERIMENTAL | Eight subjects will receive single dose of GSK2981710 in the form of 30 g MCT powder daily for 14 days. |
| Part 1: GSK2981710 40 g | EXPERIMENTAL | Eight subjects will receive single dose of GSK2981710 in the form of 40 g MCT powder daily for 14 days. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Eight subjects will receive single dose of matching placebo daily for 14 days. |
| Part 2: GSK2981710 (dose to be decided from Part 1) | EXPERIMENTAL | The subjects will receive single dose of GSK2981710 in the form of MCT powder (dose to be decided from Part 1) daily for 14 days. |
| Part 2: Placebo | PLACEBO_COMPARATOR | The subjects will receive single dose of matching placebo daily for 14 days.. |
| Name | Type | Description |
|---|---|---|
| GSK2981710 | DRUG | Will be available as 10 g medium-chain triglycerides (MCT) powder sachet that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast |
| Placebo | DRUG | Will be available as matching powder that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast |
Inclusion Criteria: * Male or female individuals between the ages of 55 years and 80 years inclusive. * A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined ...