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…
ID
Source
Brief title
Condition
- Aural disorders NEC
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome variables of three balance assessments with accelerometry (with and
without dual-task) the 160-meter walking test, the Timed Up & Go test (TUG),
and the FICSIT-4 test.
Secondary outcome
Secondary outcome measures are: visual reaction time (indicator for attention),
cognition (Mini Mental State Examination, 7 Minute Screen, Frontal Assessment
Battery, STROOP color word test, and Digit Span), activities of daily living
(by IDDD), and fall events.
Background summary
Acetylcholine esterase (AChE) inhibitors are current symptomatic treatments for
patients with Alzheimer's disease (AD). It is known that the performance of
attention-demanding dual task increases gait variability and walking
instability in elderly with cogntive impairments. Given that AChE inhibitors
improve attention and executive function in patients with AD, it is
hypothesized that treatment with the AChE inhibitor galantamine would improve
cognitive dual-task-related changes in gait variability and stability among
patients with AD.
Study objective
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). 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.
Study design
Non-random controlled intervention study with a multiple A0A1B1A2A3 time series
design with a duration of 12 months.
Intervention
Treatment with galantamine, by regular titration schedule.
Study burden and risks
There are no risks for patients to participate in the present study. Since
treatment with galantamine is indicated by the patient's doctor, participation
to the present study will not lead to extra risks for the patient. The
treatment given by the patient's doctor is the same, whether patients are
participating in the present study or not. Furthermore, the patient's burden is
reduced to a minimum, since pre- and post-measurements will take place at the
hospital during regular visits, and during the intervention period patients
will be visited at home for balance assessments. Per visit at the hospital, it
will take about 2 hr (maximum) to assess the tests. Assessments at the
patient's home, will take about 30 minutes.
Louwesweg 6
1266 EC Amsterdam
NL
Louwesweg 6
1266 EC Amsterdam
NL
Listed location countries
Age
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.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-006011-62-NL |
| CCMO | NL38747.048.11 |