Memory, Ageing, and the Cholinergic Systema combined fMRI and PET study - MACS

Phase 1

• Conditions: 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).

• Registration Number: EUCTR2008-008896-32-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-21
• Study Completion: 2014-05-07
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified