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

Ludwig Boltzmann Gesellschaft80 enrolled

Overview

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) .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Elderly

Interventions

DonepezilDRUG

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

Eligibility

Sex: ALLMin age: 70 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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);

Locations (1)

Ludwig Boltzmann Institute

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

Serum IGF1

Time frame: one year

Secondary Outcomes

Growth hormone, body composition variables

Time frame: one year

Data from ClinicalTrials.gov

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