The ACER-study - examining the effects of galantamine on gait.

• Conditions: Dementia of the Alzheimer type; MedDRA version: 14.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-006011-62-NL
• Lead Sponsor: Slotervaart Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-11
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients will be included for the present study when they are (a) aged 65 years or older; (b) diagnosed with mild to moderate Alzheimer's disease (according to the criteria of the DSM-IV and the NINCDS-ADRDA); and (c) able to walk for at least 160 meter without using any assistive device.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Patients will be excluded from the present study when they (a) have had any treatment with acetylcholine esterase inhibitors during the three months before inclusion; (b) have any mobility problems due to (lateral) neurological or orthopedic disorders with function limitations of one or both legs; (c) have severe visual impairments; or (d) are unable to understand and follow simple verbal instructions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the present study is to examine the effects of treatment with galantamine among patients with AD on the variability and stability of walking (with and without dual-task), functional mobility, standing balance, and cognitive functions (e.g. attention and executive functions). ;Secondary Objective: Furthermore, the relation between variability and stability of walking with and without dual-tasking, and cognitive functions (e.g. attention and executive functions), and activities of daily living, will be examined.;Primary end point(s): Statistically significant difference in outcome parameters between intervention and control group after 6 months of galantamine use.;Timepoint(s) of evaluation of this end point: After 12 months, a half-time evaluation will be done.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None