Safety and effectiveness of a novel drug for Alzheimer's disease on cognitive performance in the elderly
Phase 1
Completed
- Conditions
- Alzheimer's DiseaseNervous System Diseases
- Registration Number
- ISRCTN12371179
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
1. Aged 65+ years
2. Blood pressure =140/90 mmHg at screening
3. Heart rate between 45 and 100 bpm at screening
Exclusion Criteria
1. Use of antihypertensive drugs prior to and during the study period
2. Consumption of alcohol and caffeine-containing products, use of nicotine-containing products, and use of drugs influencing CYP3A4 and CYP2D6 activity prior to and during the study
3. Poor or ultra-rapid CYP2D6 metabolizer discovered on genotype screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Safety assessed by monitoring and recording of adverse events (AEs), vital signs, ECG, 5-hour Holter monitoring, and safety chemistry and hematology blood sampling (9 to 15 times) within the first 8 hrs after starting the administration, at 12 and 24 hrs post-dose in parts A and B, and between 7 and 11 days post-dose in Part B.<br> 2. Pharmacokinetics of HTL0009936 assessed through continuous urine collection. PK blood samples were collected according to the same schedule pre-dose (9 to 15 times) within the first 8 hrs after starting the administration, at 12 and 24 hrs post-dose in parts A and B, and between 7 and 11 days post-dose in Part B.<br>
- Secondary Outcome Measures
Name Time Method