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

This is an interventional basic science trial for Alzheimer's Disease Read More

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).