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

Ludwig Boltzmann Gesellschaft

Status

Completed

Conditions

Elderly

Treatments

Drug: Donepezil

Study type

Interventional

Funder types

Other

Identifiers

Ethics-commission: 05-052-0605

GH-003

EudraCT-Nr. 2005-001315-22

Details and patient eligibility

About

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) .

Enrollment

80 patients

Sex

All

Ages

70 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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);