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Clinical Trials/NCT00533065
NCT00533065
Completed
Not Applicable

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

Ludwig Boltzmann Gesellschaft1 site in 1 country80 target enrollmentSeptember 2007
ConditionsElderly

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elderly
Sponsor
Ludwig Boltzmann Gesellschaft
Enrollment
80
Locations
1
Primary Endpoint
Serum IGF1
Status
Completed
Last Updated
16 years ago

Overview

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) .
Registry
clinicaltrials.gov
Start Date
September 2007
End Date
July 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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)

Study Sites (1)

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