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Effects of Donepezil on Deficits Associated With Age-Related Decrease of Growth Hormone (GH-003)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533065
First Posted: September 21, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ludwig Boltzmann Gesellschaft
  Purpose

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) .

Condition Intervention
Elderly Drug: Donepezil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of the Cholinesterase Inhibitor Donepezil on Organic and Functional Deficits Associated With Age-Related Decrease of Growth Hormone

Resource links provided by NLM:


Further study details as provided by Ludwig Boltzmann Gesellschaft:

Primary Outcome Measures:
  • Serum IGF1 [ Time Frame: one year ]

Secondary Outcome Measures:
  • Growth hormone, body composition variables [ Time Frame: one year ]

Enrollment: 80
Study Start Date: September 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Donepezil
    week1 - week12: 1 tablet per day (5mg) week13 - week52: 1 tablet per day (10mg)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 80 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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);
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533065


Locations
Austria
Ludwig Boltzmann Institute
Vienna, Austria, 1220
Sponsors and Collaborators
Ludwig Boltzmann Gesellschaft
Investigators
Study Director: Karl H Tragl, MD Ludwig Boltzmann Institute of Aging Research
  More Information

Additional Information:
Responsible Party: Karl Heinz Tragl MD, Ludwig Boltzmann Institute of Aging Research
ClinicalTrials.gov Identifier: NCT00533065     History of Changes
Other Study ID Numbers: GH-003
EudraCT-Nr. 2005-001315-22
Ethics-commission: 05-052-0605
First Submitted: September 19, 2007
First Posted: September 21, 2007
Last Update Posted: October 12, 2017
Last Verified: August 2009

Keywords provided by Ludwig Boltzmann Gesellschaft:
Aging

Additional relevant MeSH terms:
Hormones
Donepezil
Cholinesterase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Nootropic Agents