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

This study has been completed.
Sponsor:
Information provided by:
Ludwig Boltzmann Gesellschaft
ClinicalTrials.gov Identifier:
NCT00533065
First received: September 19, 2007
Last updated: August 6, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Growth hormone, body composition variables [ Time Frame: one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   70 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: September 19, 2007
Last Updated: August 6, 2009
Health Authority: Austria: Ethikkommission

Keywords provided by Ludwig Boltzmann Gesellschaft:
Aging

Additional relevant MeSH terms:
Cholinesterase Inhibitors
Donepezil
Hormones
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014