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Completed

NCT Number: NCT00533065

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

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) .

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Key information

Conditions

Elderly

Age range

70 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ludwig Boltzmann Institute

Vienna, State of Vienna, 1220, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Donepezil

Drug

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

Primary outcomes

  1. Serum IGF1

    Time frame: one year

Secondary outcomes

  1. Growth hormone, body composition variables

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Ludwig Boltzmann Gesellschaft

Other

Registry information

Official study title

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

Acronym: GH-003

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 21, 2007
Registry last updated
Aug 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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