Effects of Donepezil on Deficits Associated With Age-Related Decrease of Growth Hormone

Not Applicable

Completed

• Conditions: Elderly

• Registration Number: NCT00533065
• Lead Sponsor: Ludwig Boltzmann Gesellschaft

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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-21
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum IGF1	one year

Secondary Outcome Measures

Name	Time	Method
Growth hormone, body composition variables	one year

Trial Locations

Locations (1)

Ludwig Boltzmann Institute; 🇦🇹 Vienna, Austria