ElderlyGH-003NCT00533065
Effects of Donepezil on Deficits Associated With Age-Related Decrease of Growth Hormone
A study testing Donepezil in people with Elderly, run by Ludwig Boltzmann Gesellschaft at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Donepezil
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged between 70 and 80 years
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Cholinesterase Inhibitor Donepezil on Organic and Functional Deficits Associated With Age-Related Decrease of Growth Hormone
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) .
- Conditions
- Elderly
- Being tested
- Donepezil
- Keywords
- Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
week1 - week12: 1 tablet per day (5mg) week13 - week52: 1 tablet per day (10mg)
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IGF1
Measured: one year
Secondary outcomes (1)
Growth hormone, body composition variables
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Gesellschaft
- Sponsor type
- University, hospital or other
- Investigators
- Karl H Tragl, MD, Study director, Ludwig Boltzmann Institute of Aging Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533065
- Sponsor's protocol ID
- GH-003
- Other IDs
- EudraCT-Nr. 2005-001315-22, Ethics-commission: 05-052-0605
- Acronym
- GH-003
- Status last verified
- Aug 2009
- First submitted
- 19 Sep 2007
- Last updated
- 7 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Cholinesterase Inhibitor Donepezil on Organic and Functional Deficits Associated With Age-Related Decrease of Growth Hormone
- ClinicalTrials.gov ID
- NCT00533065
- Acronym / sponsor ID
- GH-003 / GH-003
- Conditions
- Elderly
- Keywords
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ludwig Boltzmann GesellschaftUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Aged between 70 and 80 years
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezilweek1 - week12: 1 tablet per day (5mg) week13 - week52: 1 tablet per day (10mg) | Drug | – |
Primary outcome
Serum IGF1
Time frame: one year
1 secondary outcome
Growth hormone, body composition variables
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl H Tragl, MD study director
Ludwig Boltzmann Institute of Aging Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donepezil in people with Elderly, run by Ludwig Boltzmann Gesellschaft at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IGF1 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2009.