Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Phase 1, Exploratory Study Investigating the Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects

Heptares Therapeutics Limited1 site in 1 country54 target enrollmentOctober 2015

ConditionsAlzheimer's Disease

InterventionsHTL0009936 HTL0009936 matching placebo

Overview

Phase: Phase 1
Intervention: HTL0009936
Conditions: Alzheimer's Disease
Sponsor: Heptares Therapeutics Limited
Enrollment: 54
Locations: 1
Primary Endpoint: Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To determine if treatment with HTL0009936 will lead to changes in neural activity, measured using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and working memory, learning and executive functioning.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

February 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Heptares Therapeutics Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy on the basis of medical history, physical examination, vital signs, 12-lead ECG, haematology, blood chemistry, urinalysis and a pre-study psychological assessment.
•Mini Mental State Examination (MMSE) Score of ≥
•Intermediate or extensive metaboliser as determined by CYP2D6 genotype.
•Fluent English speaker.
•Right-handed.
•Not a regular smoker

Exclusion Criteria

•Recreational drug use within 3 months prior to Screening Visit.
•Positive alcohol breath test.
•Positive urine drug screen.
•Consumption of large amounts of caffeinated drinks.
•Consumption of any food or any drinks containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges.
•Ultra-rapid or poor metabolizer as determined by CYP2D6 genotype.
•By self-report, taking two or more daytime naps per week which in the opinion of the investigator is likely to interfere with the ability of the subject to complete the study procedures.
•History of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions.
•Personal or family history of congenital long QT syndrome or sudden death.
•Concomitant use of drugs that are metabolised by and/or are inhibitors of CYP2D

Arms & Interventions

HTL0009936 high dose

high dose infusion

Intervention: HTL0009936

HTL0009936 low dose

low dose infusion

Intervention: HTL0009936

HTL0009936 matching placebo

matching infusion

Intervention: HTL0009936 matching placebo

Outcomes

Primary Outcomes

Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks

Time Frame: Day 1

Secondary Outcomes

BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during cognitive tasks(Day 1)
cerebral blood flow, assessed using Arterial Spin Labelling (ASL)(Day 1)
adverse events(Day 1)
blood pressure(Day 1)
12-lead electrocardiogram(Day 1)