Elderly
Conditions
Keywords
Aging
Brief summary
The planned study has two purposes: 1. It is to provide evidence that the administration of a cholinesterase inhibitor will result in an increase of IGF-I (primary variable) and in an increase of the secretion growth hormone (secondary variable) that can be maintained throughout the treatment-period of one year. 2. The study also tests the hypothesis that maintenance of increased blood levels of growth hormone and IGF-I can stop or delay the age-related changes of body composition (secondary variables) .
Interventions
DRUGDonepezil
week1 - week12: 1 tablet per day (5mg) week13 - week52: 1 tablet per day (10mg)
Sponsors
Ludwig Boltzmann Gesellschaft
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 70 and 80 years
Exclusion criteria
* Cardiac arrhythmias (sick sinus syndrome, AV block, sino-atrial block), * Treatment with beta-blockers, NSAIDs or cholinergic agonists, * Known hypersensitivity to donepezil hydrochloride, piperidine derivatives or to any excipients used in the formulation, * Gastric and duodenal ulcer, * Severe renal and hepatic impairment, * Urinary congestion (prostatic hypertrophy), * Obstructive pulmonary disease (bronchial asthma);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum IGF1 | one year |
Secondary
| Measure | Time frame |
|---|---|
| Growth hormone, body composition variables | one year |
Countries
Austria
Outcome results
None listed