Clinical trial NCT02546310: Phase 1 Study Investigating Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Nxera Pharma UK Limited
Sponsor class: INDUSTRY
Collaborators: name: P1vital Limited
First posted: 2015-09-10
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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 ≥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).

Primary outcomes:
measure: Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks
timeFrame: Day 1
Secondary outcomes:
measure: BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during cognitive tasks
timeFrame: Day 1
measure: cerebral blood flow, assessed using Arterial Spin Labelling (ASL)
timeFrame: Day 1
measure: adverse events
timeFrame: Day 1
measure: blood pressure
timeFrame: Day 1
measure: 12-lead electrocardiogram
timeFrame: Day 1
Other outcomes:
measure: event related potentials
timeFrame: Day 1
Locations:
city: Manchester
country: United Kingdom
facility: Neuroscience and Psychiatry Unit
Study officials:
References: