Healthy volunteers MedDRA version: 12.0 Level: LLT Classification code 10012271 Term: Dementia Alzheimer's type MedDRA version: 12.0 Level: LLT Classification code 10013113 Term: Disease Parkinson's
Conditions
Interventions
Trade Name: Nacom
Pharmaceutical Form: Tablet
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Current Sponsor code: PR04
Other descriptive name: L-Dopa
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Otto-von-Guericke University, Medical Faculty, Dpt. of Neurology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy subjects between 18-30 years (young group), healthy subjects between 60-80 years (old group) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy, nursing, glaucoma, severe heart, lung or liver disease, contraindications against MRI, psychiatric co-morbidity, unable to understand the study, intake of anticholinergic or antidopaminergic drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effects of IMPs on memory and attention performance (reaction times, accuracy);Secondary Objective: Age dependency of the above effects?;Primary end point(s): Memory and attention performance as assessed by neuropsychological tests after treatment with placebo vs. IMP 1 or placebo vs IMP 2, respectively. | — |
Countries
Germany
Outcome results
None listed