Dementia of the Alzheimer type MedDRA version: 14.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Reminyl Tablets 4mg, Reminyl Tablets 8mg, Reminyl Tablets 12mg
Product Name: galantamine
Pharmaceutical Form: Tablet
INN or Proposed INN: GALANTAMINE
CAS Number: 357-70-0
Current Sponsor c
Sponsors
Slotervaart Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Netherlands
Contacts
Public ContactMaartje de Groot
Slotervaart Hospital
Outcome results
None listed