A study to evaluate the effects of RO7269162 on the body following oral administration in presymptomatic gene mutation carriers and non-carriers from the same kindred in Alzheimer’s Disease
- Conditions
- Nervous System DiseasesAutosomal-dominant Alzheimer’s Disease
- Registration Number
- ISRCTN75434529
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 24
1. 18 to 25 years of age inclusive
2. Membership in gene mutation carrier kindred. Gene mutation carrier or non-carrier status will have been confirmed prior to or during the screening period
3. Body mass index (BMI) of 18-32 kilograms per metre square (kg/m²) inclusive
1. Any clinically relevant finding, condition or disease detected during the medical interview/physical examination at screening or Day -1.
2. History or evidence of any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs, including surgical history affecting gastric motility or altering the gastrointestinal tract.
3. History of convulsions
4. Participants who, in the investigator`s judgment, pose a suicidal or homicidal risk
5. Vaccination within 6 weeks prior to Day 1 including influenza and/or SARS-CoV-2/COVID-19 vaccination.
6. Positive result on human immunodeficiency virus 1 (HIV1) and HIV2, hepatitis C virus (HCV) or hepatitis B (HBV).
7. Participants who test positive for acute respiratory syndrome coronavirus 2 (SARSCoV-2) on admission to the study site
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Time course of PD biomarkers measured using blood samples collected at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15<br> 2. Change in PD biomarkers measured using blood samples at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15<br> 3. Relationship between RO7269162 exposure and PD responses related to biomarkers measured using blood samples collected at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Maximum observed plasma concentration (Cmax) of RO7269162 (and its metabolite(s) as appropriate) measured using blood samples collected at multiple timepoints on Days 1 and 7<br> 2. Area under the plasma concentration-time curve (AUC) from zero up to 24 hours (h) (AUC0-24h) of RO7269162 (and its metabolite(s) as appropriate) measured using blood samples collected at multiple timepoints on Days 1 and 7<br> 3. Number of participants with adverse events (AEs) and severity of AEs from signing of Informed Consent Form up to follow up visit at Day 15<br>