Patients with mild cognitive impairment (MCI) (50-80 years), who are at greater risk of developing alzheimer's dementia will be recruited in the present study and will be compared to an age-matched group of healthy subjects (50-80 years).
Conditions
Interventions
Trade Name: Exelon
Pharmaceutical Form: Capsule
INN or Proposed INN: Rivastigmine Hydrogen Tartrate
CAS Number: 129101-54-8
Current Sponsor code: Uni-Koeln-1260
Concentration unit: mg milligram(s)
Con
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy older subjects (aged 50-80 years) with no neurological or psychiatric diseases and normal scores in neuropsychological tests (VLMT, MMSE, BDI, Digit Span und LPS4). Patients with MCI (aged 50-80 years) without other neurological or psychiatric diseases. MCI will be defined as amnestic MCI with isolated memory deficits without significant effect on daily living. VLMT scores > 1,5 standard deviations below normal values, MMSE score > 23, normal scores in BDI, Digit Span und LPS4, normal ADL scores, Written and informed consent. Normal neurological examination. Normal body examination including auscultation of lung and heart as well as palpation of the abdomen. Normal ECG. Systolic blood pressure 100-160 mmHg, diastolic blood pressure 50-100 mmHg heart frequency 50-100. An equal number of men and women will be tested in order to draw valid inference from the study for the general population since it is estimated that MCI is represented in men and women to the same degree. 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: Neurologic or psychiatric diseases (other than MCI). Severe lung, liver, kidney or gastrointestinal tract diseases, cancer, thyreotoxicosis, drug hypersensitiviy for rivastigmine, history of contact dermatitis under transdermal rivastigmine therapy, pregnancy or breast-feeding. Bronchial asthma, gangrene, coronary heart disease, bradycardia, cardiac arrhythmia, gastric ulcers, mechanical constipation, arterial hypotension. Medication with choline esterase inhibitors, epilepsy, arterial hypotension. Medication with anticholinergic drugs. For the MRI part: Metal parts in or on body, tattoos, claustrophobia. With the exception of MR-compatible implants in MCI-patients. PET-investigation, healthy subjects: previous nuclear medicine investigations for research purposes. Hypersensitivity to MP4A. PET-investigation, MCI patients: previous nuclear medicine investigations for research purposes in the past 10 years, if an effective dose of 10 mSv is expected to be exceeded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We want to investigate the effects of cholinergic stimulation on brain activity underlying memory in healthy older subjects and patients with mild cognitive impairment (MCI). In a double-blind, placebo-controlled crossover design we want to administer rivastigmine or placebo prior to measuring brain activity during memory paradigm using fMRI. We expect that cholinergic stimulation will enhance cognitive performance and the underlying brain activity in patients with MCI more than in healthy older controls. Therefore we will test whether there is a group difference between healthy subjects and MCI patients in the correlation of regional MP4A-PET activity (visualising the cerebral cholinergic system) and brain activity underlying memory and attention functions. We will furthermore investigate whether the effect of cholinergic stimulation (using rivastigmine) is dependent on the MP4A-PET activity and whether there is a group difference.;Secondary Objective: Secondary objectives are the investigation of 1) group differences in MP4A-acitivity, 2) group differences in brain activity underlying memory and attention processes, 3) group differences in the effect of cholinergic stimulation on behavioral measures of memory and attention, and 4) a security analysis of rivastigmine and C11-MP4A-Application ;Primary end point(s): Between-group difference in the correlation between regional MP4A-activity and brain activity underlying memory and attention functions. Between-group difference in the effect of cholinergic stimulation on brain activity. Correlation of the effect of cholinergic stimulation on brain activity with regional MP4A-activity. | — |
Countries
Germany
Outcome results
None listed