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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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Donepezil

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

Intervention Type DRUG

Eligibility Criteria

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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);

Minimum Eligible Age

70 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes