Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
Key facts
- Where
- Bonn, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 80 years old?
Source: NCT07324330, who can take part
Where in Germany
- University Hospital of BonnBonn, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Bonn
- Trial code
- NCT07324330
- Record updated
- 16 January 2026
- Original description
α-Synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are the second most common neurodegenerative diseases. In addition to progressive motor deterioration, cognitive decline is a key element of the non-motor symptom complex of these diseases. Isolated rapid eye movement (REM) sleep behavior disorder (iRBD) indicates an early stage of α-synucleinopathies, even before relevant motor or cognitive disorders are present. Therapeutic interventions in individuals with iRBD therefore have great preventive potential. In particular, increasing physical activity could have a relevant effect on neurodegenerative processes, including the preservation of cognitive functions.Read full original descriptionShow less
α-Synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are the second most common neurodegenerative diseases. In addition to progressive motor deterioration, cognitive decline is a key element of the non-motor symptom complex of these diseases. Isolated rapid eye movement (REM) sleep behavior disorder (iRBD) indicates an early stage of α-synucleinopathies, even before relevant motor or cognitive disorders are present. Therapeutic interventions in individuals with iRBD therefore have great preventive potential. In particular, increasing physical activity could have a relevant effect on neurodegenerative processes, including the preservation of cognitive functions.
The aim of the study is therefore to investigate the effects of increased physical activity in everyday life on cognitive functions in individuals with iRBD. In this randomized, double-blind, actively controlled study, an increase in physical activity will be implemented over a period of one year with the help of a motivational smartphone application. The intervention and control conditions are the same as those used in the Slow-SPEED trials, making the connection between the trials concrete. The primary outcome parameter is the change in cognitive performance in a neuropsychological test battery over one year.
Eighty individuals with iRBD and 50 age- and gender-matched individuals are being recruited at the University Hospital Bonn and the "Deutsches Zentrum für Neurodegenerative Erkrankungen" (DZNE) Bonn (German branch only). In addition to classic neuropsychological tests as the primary endpoint, magnetic resonance imaging (MRI) and blood-based markers of brain aging are being examined as secondary endpoints. This study is in close collaboration with the Slow-SPEED study (https://clinicaltrials.gov/study/NCT06993142). In addition, selected data from three separate trials-Alpha-Fit, Slow-SPEED-NL, and a sister trial in Austria currently in preparation-are planned to be synthesized into a meta-analysis.
Inclusion: 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: Relevant cardiovascular diseases; Relevant cardiovascular diseases; iRBD:; 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:; 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.