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Active, Not Recruiting

NCT Number: NCT06402838

A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)

This clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid, but have no clinical symptoms, or with a diagnosis of mild cognitive impairment. People can take part if they have a certain level of plaques (beta-amyloid) in the brain, shown by a positron emission tomography (PET) scan, a medical imaging technique in which tracers are injected to visualize specific pathological processes in the brain. People who take part in this clinical trial (participants) will be given RO7269162 OR placebo for up to about 1 and a half years. The clinical trial team will see them every 3 weeks in the first 3 months and then every 6 weeks until the end of the trial. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. The total time of participation in the clinical trial will be 90 weeks.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro de Investigación Clínica UC-CICUC, Santiago, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index (BMI) between 18 to 35 kg/m^2 inclusive at screening
  • Participants must be either cognitively unimpaired or with a diagnosis of MCI due to AD, according to the National Institute on Aging - Alzheimer's Association (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 baseline

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 active 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 baseline, and/or any other investigational treatment within five half-lives or 16 weeks prior to screening, whichever is longer

Treatment and study plan

RO7269162

Drug

Participants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks.

Placebo

Drug

Participants will receive daily doses of placebo for up to 72 weeks.

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: up to week 72

  2. Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan

    Time frame: Baseline to Week 72

Secondary outcomes

  1. Change from baseline in Aβ37 in cerebrospinal fluid (CSF)

    Time frame: Baseline to Week 72

  2. Change from baseline in Aβ38 in CSF

    Time frame: Baseline to Week 72

  3. Change from baseline in Aβ40 in CSF

    Time frame: Baseline to Week 72

  4. Change from baseline in Aβ42 in CSF

    Time frame: Baseline to Week 72

  5. Change from baseline in Aβ40 in plasma

    Time frame: Baseline to Week 72

  6. Change from baseline in Aβ42 in plasma

    Time frame: Baseline to Week 72

  7. Plasma concentrations of RO7269162

    Time frame: Baseline to Week 72

  8. CSF concentrations of RO7269162

    Time frame: Baseline to Week 72

Other outcomes

  1. Change from baseline in p-tau 217 in plasma

    Time frame: Baseline to Week 72

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 7, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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