RightFit
Not yet recruitingPhase 2

Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease

A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early Symptomatic Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the effects and safety of RO7568282 in people with early Alzheimer's disease. It compares the study drug with a placebo, a treatment with no active drug.

This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests show signs of Alzheimer's disease, using an amyloid PET brain scan or a test of fluid around the brain and spinal cord.
  • Have mild memory and thinking problems or mild dementia due to Alzheimer's disease.
  • Can swallow whole capsules.
  • Have a body mass index (BMI), a measure of weight compared with height, between 18 and 34 at screening.
  • Have a suitable study partner available.

Who can't join

  • Have another condition that may affect memory or thinking.
  • Have had unstable or serious heart or blood vessel disease within the past year.
  • Have long-term high blood pressure that is not controlled.
  • Have important abnormal results on an ECG, a test of the heart's electrical activity.
  • Have or have had serious disease of the blood vessels in the brain.
  • Have important brain changes on an MRI brain scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Evidence of AD pathological process, as confirmed by either amyloid positron emission tomography (PET) scan or cerebrospinal fluid (CSF) * Mild cognitive impairment (MCI) or mild dementia due to AD * Able to swallow whole capsules * Body mass index (BMI) within the range of 18-34 kilograms per square metre (kg/m²) (at screening) * Availability of an appropriate study partner Exclusion Criteria: * Any evidence of a condition other than AD that may affect cognition * Participants must not have unstable or clinically significant cardiovascular disease within the last year, chronic uncontrolled hypertension, or clinically significant electrocardiogram (ECG) abnormalities * History or presence of clinically significant cerebrovascular disease * Clinically significant cerebral abnormalities on magnetic resonance imaging (MRI) Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study sites (1)

NY