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

NCT02546310 | Completed Phase 1

• 1 other identifier: 9936-103
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

  Day 1

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• event related potentials

  Day 1

Study Arms (3)

HTL0009936 high dose

EXPERIMENTAL

high dose infusion

Drug: HTL0009936

HTL0009936 low dose

EXPERIMENTAL

low dose infusion

Drug: HTL0009936

HTL0009936 matching placebo

PLACEBO COMPARATOR

matching infusion

Drug: HTL0009936 matching placebo

Interventions

HTL0009936 DRUG

HTL0009936 high dose; HTL0009936 low dose

HTL0009936 matching placebo DRUG

HTL0009936 matching placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nxera Pharma UK Limited: lead
• P1vital Limited: collaborator

Study Sites (1)

Neuroscience and Psychiatry Unit

Manchester, M13 9PT, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 10, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

GB (1)