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

Elderly Clinical Trial

— GH-003  

Official title:

Effects of the Cholinesterase Inhibitor Donepezil on Organic and Functional Deficits Associated With Age-Related Decrease of Growth Hormone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533065
• Other study ID #: GH-003
• Secondary ID: EudraCT-Nr. 2005
• Status: Completed
• Phase: N/A
• First received: September 19, 2007
• Last updated: August 6, 2009
• Start date: September 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: Ludwig Boltzmann Gesellschaft
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 80 Years

Eligibility

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);

Related Conditions & MeSH terms

• Elderly

Intervention

Drug:
• Donepezil
week1 - week12: 1 tablet per day (5mg) week13 - week52: 1 tablet per day (10mg)

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann Institute	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig Boltzmann Gesellschaft

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum IGF1		one year
Secondary	Growth hormone, body composition variables		one year

External Links

•   Link