Phase 1 Study Investigating Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: HTL0009936; Drug: HTL0009936 matching placebo

• Registration Number: NCT02546310
• Lead Sponsor: Heptares Therapeutics Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-10
• Study Start: 2015-10
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 ≥24.
• 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 CYP2D6.
• Concomitant use of drugs that are substrates for the organic cation transporter 2.
• History of significant claustrophobia.
• Fulfils any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTL0009936 high dose	HTL0009936	high dose infusion
HTL0009936 low dose	HTL0009936	low dose infusion
HTL0009936 matching placebo	HTL0009936 matching placebo	matching infusion

Primary Outcome Measures

Name	Time	Method
Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks	Day 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Neuroscience and Psychiatry Unit; 🇬🇧 Manchester, United Kingdom