2023-506183-13-00
Recruiting
Phase 2
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter, Parallel-Group Study to Investigate the Safety, Tolerability, and the Effect of RO7269162 on Amyloid and Non-Amyloid Disease-Related Biomarkers following Daily Oral Administration in Participants at Risk for or at the Prodromal Stage of Alzheimer’s Disease
F. Hoffmann-La Roche AG47 sites in 6 countries202 target enrollmentStarted: March 28, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- F. Hoffmann-La Roche AG
- Enrollment
- 202
- Locations
- 47
- Primary Endpoint
- 1. Nature, incidence, severity, and outcome of AEs
Overview
Brief Summary
- To investigate the safety and tolerability of daily oral dosing of RO7269162 and to assess the effect of daily oral dosing of RO7269162 on brain amyloid accumulation
Study Design
- Allocation
- Na
- Primary Purpose
- Follow-up
- Masking
- Double (Subject, Investigator)
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Body Mass Index (BMI) between 18 to 35 kg/m2 inclusive, at screening
- •Participants must be either cognitively unimpaired or with a diagnosis of MCI due to AD, according to the NIA – AA workgroups on diagnostic guidelines for AD, and/or according to the updated NIA-AA research framework
- •Clinical Dementia Rating-Global Score (CDR-GS) of 0 or 0.5
- •Positive amyloid PET scan based on a cut-off of ≥24 CL units
- •Availability of a person (referred as a “study partner” throughout the protocol) who: (a) has frequent and sufficient contact (e.g., minimum twice a week in-person, via telephone, video calls, by e-mail or other electronic means) with the participant, and is willing and able to provide accurate information regarding the participant’s cognitive and functional abilities, signs the necessary ICF(s), and has sufficient cognitive capacity to accurately report on the participant’s cognitive and functional abilities; (b) is in sufficient good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the duration of the study; and (c) is fluent in the language of the tests used at the study site. Please note that the study partner does not need to be a family member. Every effort should be made to keep the same study partner throughout the study.
- •In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least eight weeks prior to first IMP intake
Exclusion Criteria
- •Any medical history or evidence of a condition other than AD that may affect cognition
- •History or presence of significant cardiovascular conditions and/or significant hematological disease
- •History or presence of chronic kidney disease and/or impaired hepatic function
- •Uncontrolled/poorly controlled diabetes
- •History of or activate inflammatory bowel disease
- •Have received any passive or active immunotherapy (immunoglobulin) or other long-acting biologic agent that is under evaluation or approved to prevent or postpone cognitive decline administered within 1 year prior to first IMP intake, and/or any other investigational treatment within five half-lives or 16 weeks prior to screening, whichever is longer.
Arms & Interventions
FLORBETABEN (18F)
Auxiliary
Intervention: FLORBETABEN (18F) (Drug)
Placebo RO7269162
Placebo
Intervention: Placebo RO7269162 (Drug)
FLUTEMETAMOL (18F)
Auxiliary
Intervention: FLUTEMETAMOL (18F) (Drug)
RO7269162, RO7269162, RO7269162
Test
Intervention: RO7269162 (Drug)
Outcomes
Primary Outcomes
1. Nature, incidence, severity, and outcome of AEs
1. Nature, incidence, severity, and outcome of AEs
2. Changes from baseline in vital signs, ECG parameters, Columbia-Suicide Severity Rating Scale (C-SSRS) and safety laboratory findings
2. Changes from baseline in vital signs, ECG parameters, Columbia-Suicide Severity Rating Scale (C-SSRS) and safety laboratory findings
3. Change from baseline in brain amyloid load, as measured by amyloid PET scan
3. Change from baseline in brain amyloid load, as measured by amyloid PET scan
Secondary Outcomes
- 1. Change from baseline in Aβ37, Aβ38, Aβ40 and Aβ42 in CSF and Aβ40 and Aβ42 in plasma
- 2. Plasma concentrations of RO7269162 (and its metabolite[s] as appropriate)
- 3. CSF concentrations of RO7269162 (and its metabolite[s] as appropriate)
Investigators
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
Study Sites (47)
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