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

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

This study has been completed.

First Received: September 19, 2007 Last Updated: August 6, 2009 History of Changes

Sponsored by:	Ludwig Boltzmann Gesellschaft
Information provided by:	Ludwig Boltzmann Gesellschaft
ClinicalTrials.gov Identifier:	NCT00533065

Purpose

The planned study has two purposes:

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.
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:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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:

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

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:

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

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ludwig Boltzmann Institute of Aging Research ( Karl Heinz Tragl MD )
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
ClinicalTrials.gov Identifier:	NCT00533065 History of Changes
Health Authority:	Austria: Ethikkommission

Keywords provided by Ludwig Boltzmann Gesellschaft:

Aging

Study placed in the following topic categories:

Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents

Donepezil
Cholinergic Agents
Hormones

Additional relevant MeSH terms:

Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Donepezil
Enzyme Inhibitors
Cholinergic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009