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Impact of CHOlinergic Stimulation on COgnitive and MOtor Functions and Brain Activity in Elderly Volunteers (CHOCOMO) - a randomised, placebo-controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512172-35-00
Acronym
2023-UOL-MG-004-01
Enrollment
50
Registered
2024-07-16
Start date
2025-02-17
Completion date
Unknown
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neurological disorders

Brief summary

Dual-task costs (DTC): calculated as the difference between the scores of the dual-task and single-task performances and measured as reaction time (ms) in the cognitive task and motor pedaling speed (ms) in the motor task after donepezil or placebo administration, respectively, at V1 and 2

Detailed description

Neuronal activity: measured after donepezil or placebo administration, respectively, by fMRI during task performance at visit 1 and 2, Relative cognitive and motor performances in other neuropsychological tests: 1. measured by reaction times (ms) and % correct responses in the sub-tests of TAP-M test battery and 2. measured by time (s) conducting the TUG-test variant, both after donepezil or placebo administration, respectively, at V1 and 2

Interventions

DRUGDonepezilhydrochlorid Heumann 5 mg Filmtabletten
DRUGPlacebo to match Donepezil

Sponsors

Carl Von Ossietzky Universitaet Oldenburg
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Dual-task costs (DTC): calculated as the difference between the scores of the dual-task and single-task performances and measured as reaction time (ms) in the cognitive task and motor pedaling speed (ms) in the motor task after donepezil or placebo administration, respectively, at V1 and 2

Secondary

MeasureTime frame
Neuronal activity: measured after donepezil or placebo administration, respectively, by fMRI during task performance at visit 1 and 2, Relative cognitive and motor performances in other neuropsychological tests: 1. measured by reaction times (ms) and % correct responses in the sub-tests of TAP-M test battery and 2. measured by time (s) conducting the TUG-test variant, both after donepezil or placebo administration, respectively, at V1 and 2

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026