NCT07324330 · RECRUITING
Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
This trial tests whether boosting everyday physical activity — guided by a motivational smartphone app — can slow cognitive decline in people with isolated REM sleep behavior disorder, a condition that often signals early Parkinson's or Lewy body disease before major symptoms appear. Participants wear a fitness tracker and use the app for one year. It is a Phase NA behavioral study, meaning it tests a lifestyle intervention rather than a drug, with no regulatory approval process involved.
Eligibility criteria
Inclusion Criteria: iRBD: * Age: 50-80 years * Polysomnographically confirmed diagnosis of iRBD * Maximum of 120 minutes of sports/outdoor activities per day * Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase * Basic smartphone skills * Sufficient knowledge of German (native language, C1 or C2) * Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer) * Consent to be informed of any additional findings Healthy controls: * Age: 50-80 years * Maximum of 120 minutes of sports/outdoor activities per day * Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase * Basic smartphone skills * Sufficient knowledge of German (native language, C1 or C2) * Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer) * Consent to be informed of any additional findings Exclusion Criteria: iRBD: * Relevant cardiovascular diseases * Problems with dexterity or cognitive impairments that make it difficult to use a smartphone * Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study * Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible) Healthy controls: * Relevant cardiovascular diseases * Problems with dexterity or cognitive impairments that make it difficult to use a smartphone * Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study * Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible) * clinically diagnosed iRBD
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-16