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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02546310
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : February 3, 2017
P1vital Limited
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: HTL0009936 Drug: HTL0009936 matching placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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 Start Date : October 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HTL0009936 high dose
high dose infusion
Drug: HTL0009936
Experimental: HTL0009936 low dose
low dose infusion
Drug: HTL0009936
Placebo Comparator: HTL0009936 matching placebo
matching infusion
Drug: HTL0009936 matching placebo

Primary Outcome Measures :
  1. Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during cognitive tasks [ Time Frame: Day 1 ]
  2. cerebral blood flow, assessed using Arterial Spin Labelling (ASL) [ Time Frame: Day 1 ]
  3. adverse events [ Time Frame: Day 1 ]
  4. blood pressure [ Time Frame: Day 1 ]
  5. 12-lead electrocardiogram [ Time Frame: Day 1 ]

Other Outcome Measures:
  1. event related potentials [ Time Frame: Day 1 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02546310

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United Kingdom
Neuroscience and Psychiatry Unit
Manchester, United Kingdom, M13 9PT
Sponsors and Collaborators
Heptares Therapeutics Limited
P1vital Limited

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Responsible Party: Heptares Therapeutics Limited Identifier: NCT02546310     History of Changes
Other Study ID Numbers: 9936-103
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders