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
| ISRCTN | ISRCTN75434529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75434529 |
| Secondary identifying numbers | BP44161 |
- Submission date
- 02/12/2022
- Registration date
- 05/12/2022
- Last edited
- 18/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims:
RO7269162 is an experimental drug being developed for the possible treatment of Alzheimer’s Disease (AD). AD is a slowly developing disease of the brain that affects memory and other brain functions. Health Authorities have not approved RO7269162 for the treatment of AD or any other disease.
The main purpose of this study is to investigate the effect of RO7269162 on biological molecules found in the blood that are indicative of a disease (biomarker) in participants who are carriers of an altered/changed gene (mutation).
Who can participate?
People between the ages of 18 to 25 years (both inclusive)
What does the study involve?
Participants will have to be a part of this study for approximately 14 to 15 weeks. This study will have four parts:
1. Screening Period: Participants will undergo certain screening tests and/or procedures to make sure that they are eligible to take part in this study. Participants will have a screening visit up to 12 weeks before the study starts.
2. In-house Period: Participants will be admitted to the clinical site in the afternoon few days before the study medication is administered and they will have to stay in the clinic for a stipulated period of time. Participants will be allowed to go back home no earlier than 72 hours after the last study medication administration.
During this period participants will receive RO7269162 by mouth for multiple days.
3. Ambulatory visit: Participants will have to return to the clinic for an ambulatory visit on Day 12. This visit is for checking on the participants after treatment is finished.
4. Follow-up visit: Participants will have to return to the clinic 8 to 10 days after the last dosing for a final safety follow-up visit.
What are the possible benefits and risks of participating?
Participants may not receive any health benefits from the study drug. However, the information learned in this study will help in the further development of RO7269162 and may benefit patients with AD in future.
Reasonable travel costs, food costs and other reasonable out of pocket expenses will be refunded to the participants.
Participants may experience side effects from the treatments or procedures in this study. Side effects can vary from mild to serious and may be different from person to person. As RO7269162 is a new experimental drug with limited testing in humans, not all the side effects that could occur are known at this time.
Muscle aches in the legs, headache, nausea and light-headedness are the known side effects of RO7269162.
There may be a risk in exposing an unborn child to the study treatment, and not all potential consequences are known at this time. Women and men must take precautions to avoid exposing an unborn child or a breastfed baby to the study treatment. Participant or their partner who are pregnant, currently breastfeeding or are planning to become pregnant during the study cannot take part in this study.
Where is the study run from?
F. Hoffmann-La Roche Ltd (Switzerland)
When is the study starting and how long is it expected to run for?
July 2022 to October 2024
Who is funding the study?
F. Hoffmann-La Roche Ltd (Switzerland)
Who is the main contact?
global-roche-genentech-trials@gene.com
Contact information
Public
Building 1, Grenzacherstrasse 124
Basel
CH-4070
Switzerland
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Phase I single-centre repeated dose adaptive study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A single-center, adaptive, repeated dose, phase I study to investigate the pharmacodynamics of RO7269162 following oral administration in presymptomatic carriers and in non-carriers of a genetic mutation from the same kindred in autosomal-dominant Alzheimer’s Disease |
| Study objectives | The purpose of this study is to assess the effect of multiple doses of RO7269162 on pharmacodynamic (PD) biomarkers in carriers of a specific genetic mutation. The study also aims to characterize the pharmacokinetic-pharmacodynamic (PKPD) relationships of RO7269162 in carriers of a genetic mutation. |
| Ethics approval(s) | Approved 04/11/2022, El Hospital Con Alma Pablo Tobón Uribe, Comité De Investigaciones y Ética En Investigaciones (Calle 78B No. 69-240, Medellín - Colombia; +57 604 445 90 00; comiteinvestigaciones@hptu.org.co) |
| Health condition(s) or problem(s) studied | Autosomal-dominant Alzheimer’s disease |
| Intervention | Cohort 1: Participants will receive RO7269162, at dose level 1, orally, for up to 7 days Cohort 2: Participants will receive RO7269162, at dose level 2, orally, for up to 7 days Follow up to day 15. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | RO7269162 |
| Primary outcome measure | 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 2. Change in PD biomarkers measured using blood samples at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15 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 |
| Secondary outcome measures | 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 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 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 |
| Overall study start date | 31/07/2022 |
| Completion date | 07/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 24 |
| Total final enrolment | 20 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 15/06/2023 |
| Date of final enrolment | 30/11/2023 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Medellín, Antioquia
0500
Colombia
Sponsor information
Industry
Building 1, Grenzacherstrasse 124
Basel
CH-4070
Switzerland
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com | |
| Website | https://www.roche.com/about/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement. |
Editorial Notes
18/06/2025: Total final enrolment corrected from 40 to 20.
17/06/2025: Total final enrolment added.
13/06/2025: The overall study end date was changed from 17/12/2023 to 07/10/2024.
05/12/2022: Trial's existence confirmed by El Hospital Con Alma Pablo Tobón Uribe.
