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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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HTL0009936 high dose

high dose infusion

Group Type EXPERIMENTAL

HTL0009936

Intervention Type DRUG

HTL0009936 low dose

low dose infusion

Group Type EXPERIMENTAL

HTL0009936

Intervention Type DRUG

HTL0009936 matching placebo

matching infusion

Group Type PLACEBO_COMPARATOR

HTL0009936 matching placebo

Intervention Type DRUG

Interventions

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HTL0009936

Intervention Type DRUG

HTL0009936 matching placebo

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes