Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects

Alzheimer's Disease Clinical Trial

Official title: Effects of Medium-Chain Triglycerides on Cognitive Function in Older Subjects With Age-Related Cognitive Decline

Status Completed

Clinical Trial Summary

This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK] Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study investigating the PK profile of four different doses of GSK2981710. Eight subjects will receive a single dose of GSK2981710 10 gram (g), 20 g, 30 g, 40 g or placebo in the morning and have PK assessments (every 0.5 hrs up to 8 hrs post-dose) throughout the day in each period. Each subject will complete a total of four dosing sessions and 4 days of PK assessments in 2 weeks. The Part 1 PK data will be used for dose selection and pharmacodynamic (PD) assessment period in Part 2. If the data from Part 1 is inconclusive, an additional 8 subjects may be recruited and Part 1 repeated (possibly dropping some doses) to increase confidence. A subject's total participation in Part 1 of the study will last a maximum of approximately 7 weeks including screening. Subjects who have completed Part 1 may be screened for eligibility and enrolled for Part 2.

Part 2 (PD Assessment) is a double blind randomized, placebo-controlled 2-period crossover design with 14-day treatment periods investigating the efficacy (cognitive performance) and tolerability (gastrointestinal [GI] side effects) of single daily dose of GSK2981710 selected from Part 1. Part 2 of the study will include the Screening period, two Baseline assessments (6-8 days before each Treatment period) and two 14-day treatment periods separated by a minimum 7-day washout period and follow-up visit of 3 to 5 days. Approximately 50 to 80 subjects will be randomized to either GSK2981710 or placebo. The PD assessments will be performed on 6 occasions for each subject: at 2 baselines (6 to 8 days before Day 1 of each treatment period), post-dose on the Day 1 of each treatment period to assess acute effects and on Day 15 of each treatment period (which is the day after the final dose) to assess chronic effects. A subject's total participation in Part 2 of the study will last approximately up to 12 weeks including screening.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

• NCT number: NCT01702480
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2012
• Completion date: July 3, 2015