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CompletedPhase 1

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

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

Asset

HTL0009936

Listed sites

1

Recruiting sites

-

Enrollment

54

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•MMSE ≥24•MRI contraindications excluded

Primary endpoint

•Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID9936-103
NCT IDNCT02546310

Timeline

Milestones

Study first posted2015-09-10estimated
Study start2015-10 (month precision)
Primary completion2017-02actual (month precision)
Study completion2017-02actual (month precision)
Last update posted2017-02-03estimated

Assets

Drug assets

HTL0009936

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

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).

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Neuroimaging
3
Safety / tolerability / PK
2
Other clinical outcomes
1
Other (unclassified)
1

Neuroimaging

3 endpoints
Primary/protocol endpoint

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

Time frame:Day 1

descriptive

Secondary/protocol endpoint

BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during cognitive tasks

Time frame:Day 1

descriptive

Secondary/protocol endpoint

cerebral blood flow, assessed using Arterial Spin Labelling (ASL)

Time frame:Day 1

descriptive

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

adverse events

Time frame:Day 1

event count, event

Secondary/protocol endpoint

12-lead electrocardiogram

Time frame:Day 1

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

blood pressure

Time frame:Day 1

descriptive

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

event related potentials

Time frame:Day 1

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.