Impact of CHOlinergic Stimulation on COgnitive and MOtor Functions and Brain Activity in Elderly Volunteers (CHOCOMO) - a randomised, placebo-controlled trial
- Conditions
- neurological disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-512172-35-00
- Lead Sponsor
- Carl Von Ossietzky Universitaet Oldenburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Healthy volunteers, Male or female aged = 50 years without upper age limit, Right-handed, BMI 18 - 32 kg/m2, Suitable for MRI, Written informed consent obtained according to international guidelines and local laws, Capacity to understand the nature, significance and consequences of the trial and the trial related procedures and to comply with them
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, Planned surgery within the study and follow-up period, Metal implants and/or components on the body that cannot be removed, 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, Previous participation in this trial, Known abuse of medication, drugs or alcohol, Person who is in a relationship of dependence/employment with the Sponsor or the Principle Investigator, Person who lack of sufficient communication skills in the German language, Person who is institutionalised by court or official order, Current or planned pregnancy, nursing period, 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, Known QTc prolongation and/or family history of QTc prolongation, Known electrolyte imbalance (hypokalemia, hypomagnesemia), Known claustrophobia, Known defective vision of > +/- 6 dioptres if not corrected by contact lenses, Known hypersensitivity to the active substances, piperidine derivatives or any of the excipients of the IMP / Placebo according to the SmPc, 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, 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, Abnormal ECG values during screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method