NCT00533065CompletedNot Applicable
Effects of the Cholinesterase Inhibitor Donepezil on Organic and Functional Deficits Associated With Age-Related Decrease of Growth Hormone
Ludwig Boltzmann Gesellschaft2 sites in 1 country80 target enrollmentStarted: September 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Serum IGF1
Study Overview
Brief Summary
The planned study has two purposes:
- 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.
- 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) .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 70 Years to 80 Years (Older Adult)
- Sex
- All
- Accepts 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);
Outcomes
Primary Outcomes
Serum IGF1
Time Frame: one year
Secondary Outcomes
- Growth hormone, body composition variables(one year)
Investigators
Study Sites (2)
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