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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546310
• Other study ID #: 9936-103
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2015
• Last updated: February 2, 2017
• Start date: October 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Heptares Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• HTL0009936

• HTL0009936 matching placebo

Locations

Country	Name	City	State
United Kingdom	Neuroscience and Psychiatry Unit	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Heptares Therapeutics Limited	P1vital Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	event related potentials		Day 1
Primary	Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks		Day 1
Secondary	BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during cognitive tasks		Day 1
Secondary	cerebral blood flow, assessed using Arterial Spin Labelling (ASL)		Day 1
Secondary	adverse events		Day 1
Secondary	blood pressure		Day 1
Secondary	12-lead electrocardiogram		Day 1