NCT00533065

Brief Summary

The planned study has two purposes:

  1. 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. 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) .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

1.8 years

First QC Date

September 19, 2007

Last Update Submit

August 6, 2009

Conditions

Elderly

Keywords

Aging

Outcome Measures

Primary Outcomes (1)

  • Serum IGF1

    one year

Secondary Outcomes (1)

  • Growth hormone, body composition variables

    one year

Interventions

DonepezilDRUG

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

Eligibility Criteria

Age70 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged between 70 and 80 years

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Boltzmann Institute

Vienna, Vienna, 1220, Austria

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Karl H Tragl, MD

    Ludwig Boltzmann Institute of Aging Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

September 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

AU(1)