DONEPEZIL HYDROCHLORIDE for Neurological disorders

Inclusion criteria

• {"criterion_text":"- Healthy volunteers"}
• {"criterion_text":"- Male or female aged ≥ 50 years without upper age limit"}
• {"criterion_text":"- Right-handed"}
• {"criterion_text":"- BMI 18 - 32 kg/m2"}
• {"criterion_text":"- Suitable for MRI"}
• {"criterion_text":"- Written informed consent obtained according to international guidelines and local laws"}
• {"criterion_text":"- Capacity to understand the nature, significance and consequences of the trial and the trial related procedures and to comply with them"}

Exclusion criteria

• {"criterion_text":"- Known clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, urological, immunologic, neurologic, oncologic or psychiatric disease or other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results"}
• {"criterion_text":"- Planned surgery within the study and follow-up period"}
• {"criterion_text":"- Metal implants and/or components on the body that cannot be removed"}
• {"criterion_text":"- Participation in any other interventional clinical trial within the last 30 days before the start of this trial and/or simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed"}
• {"criterion_text":"- Previous participation in this trial"}
• {"criterion_text":"- Known abuse of medication, drugs or alcohol"}
• {"criterion_text":"- Person who is in a relationship of dependence/employment with the Sponsor or the Principle Investigator"}
• {"criterion_text":"- Person who lack of sufficient communication skills in the German language"}
• {"criterion_text":"- Person who is institutionalised by court or official order"}
• {"criterion_text":"- Current or planned pregnancy, nursing period"}
• {"criterion_text":"- Failure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception"}
• {"criterion_text":"- Known QTc prolongation and/or family history of QTc prolongation"}
• {"criterion_text":"- Known electrolyte imbalance (hypokalemia, hypomagnesemia)"}
• {"criterion_text":"- Known claustrophobia"}
• {"criterion_text":"- Known defective vision of > +/- 6 dioptres if not corrected by contact lenses"}
• {"criterion_text":"- Known hypersensitivity to the active substances, piperidine derivatives or any of the excipients of the IMP / Placebo according to the SmPc"}
• {"criterion_text":"- Current use and/or use up to 30 days prior to study entry of: 1. Nicotine; 2. Substances that influence the QTc interval according to SmPC; 3. Non-steroidal anti-inflammatory drugs (NSAIDs) on a regular long-term basis; 4. Donepezil hydrochloride or related drugs with anti- and cholinergic activity and neuromuscular blocking agents according to SmPc; 5. CYP3A4 and 2D6 inhibitory and inducing substances according to SmPc: chinidin, itraconazole, erythromycin, fluoxetine, rifampicin, phenytoin, carbamazepine, systemic use of ketoconazole; 6. Beta blockers"}
• {"criterion_text":"- After at least 3 minutes of rest in a sitting position, subjects should be excluded from the study if they have the following vital signs at screening: 1. systolic blood pressure outside the range of 90-145 mmHg, or 2. diastolic blood pressure outside the range of 50-90 mmHg, or 3. resting heart rate outside the range of 40-100 beats per minute"}
• {"criterion_text":"- Abnormal ECG values during screening"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Calculated as difference between dual-task and single-task performance; measured as reaction time (ms) in cognitive task and motor pedaling speed (ms) in motor task after donepezil or placebo at visits 1 and 2"}

Secondary endpoints

• {"endpoint_text":"- Neuronal activity: measured after donepezil or placebo administration, respectively, by fMRI during task performance at visit 1 and 2","definition_or_measurement_approach":"Measured by functional MRI (fMRI) during task performance after donepezil or placebo at visits 1 and 2"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured by reaction times (ms) and percent correct responses in TAP-M sub-tests, and by time (s) to conduct TUG-test variant after donepezil or placebo at visits 1 and 2"}

Germany

Earliest CTIS Part Ii Submission Date

01-07-2024

Latest Decision Or Authorization Date

12-03-2025

Processing Time Days

254

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Carl Von Ossietzky Universitaet Oldenburg

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"Deutsche Forschungsgemeinschaft (DFG)","duties_or_roles":"Source of monetary support","organisation_type":""}