healty subjects
Conditions
Interventions
Group 1: IMP:
Visit 1:
- Subject information / declaration of consent
- Inclusion and exclusion criteria
- Specific medical history including current medication
- Clinical neurological examination, ph
Sponsors
Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät
Eligibility
Sex/Gender
All
Age
65 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Generally good health 2. Signed and dated written consent 3. Result of the Mini-Mental Status Test (MMST) = 26 4. Sufficient knowledge of German is available 5. Age between 65 and 90 years 6. In female subjects: postmenopause (at least 12 consecutive months of amenorrhea)
Exclusion criteria
Exclusion criteria: 1. Incompatibility with the MRI criteria 2. Severe neurological or psychiatric pre-existing conditions 3. Severe cardiovascular diseases (including diabetes mellitus requiring insulin) 4. Subjects with acute infections 5. Subjects with chronic infectious underlying diseases with possible neurological manifestations (e.g. syphilis, borreliosis) in the past 6. Taking medication which can lead to relevant interactions with L-DOPA and Domperidon Hexal 7. Fulfillment of the contraindications and warnings of Madopar LT or Domperidon HEXAL® 10 mg tablets according to the respective SmPC chapters 4.3 and 4.4 8. Use of psychotropic substances or dopaminergic, noradrenergic or cholinergic drugs 9. Allergy to coconut milk 10. Substance dependence and / or history of substance dependence 11. Relevant rhythmological abnormalities in the ECG 12. Diagnosis of severe liver (> 2-fold increased ASAT / ALAT), kidney (GFR <30 ml / min) or overt thyroid dysfunction 13. Hereditary galactose intolerance, lactase deficiency and / or glucose-galactose malabsorption 14. History (within the last 2 years) of malignancies or currently active malignancy with the exception of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin 15. History of radio or chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of the effect of dopaminergic modulation on memory consolidation, comparison of episodic memory performance after 30 minutes and after 7 days after L-DOPA administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Structural integrity of SN / VTA, LC and hippocampus using imaging methods (T1 Mp-Rage, high-resolution T2, FLAIR, MTC, QSM, as well as DTI and TOF at the discretion of the test persons) - Blood detection of cardiovascular risk factors (possible correlation with memory performance) - HbA1c - glucose - cholesterol levels - BMI and blood pressure - Indicators for age-related vascular damage in the brain (possible correlation with memory performance) - White matter hyperintensity (WMH) - Small vessel disease (SVD) - Measurements of personality and psychological characteristics (possible influence on dopaminergic values and cognitive performance) - Personality traits (BDI) - Sleep quality (PSQI) - Anxiety (STAI) - Impulsiveness (UPPS) - Physical activity (FFKA) - Depression (BDI) Verbal learning and memory test (VLMT) - Safety endpoint: number of AEs and SAEs in both arms | — |
Countries
Germany
Contacts
Public ContactElisa Lancini
Institut für Kognitive Neurologie und Demenzforschung, Medizinische Fakultät, Otto-von-Guericke-Universität Magdeburg
Outcome results
None listed