Effects of memantine treatment in institutionalised patients with Alzheimer's Disease.
Conditions
Interventions
Trade Name: Ebixa
Product Name: Ebixa
Product Code: Lu 00-800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: memantine hydrochloride
CAS Number: 41100-52-1
Current Sponsor code: Lu 00-8
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained from the patient and a relative or a legally acceptable representative prior to the initiation of any study specific procedures. 2. The patient has a diagnosis of Dementia of the Alzheimer’s type consistent with DSM-IV-TR Criteria, established before entering the nursing home and recorded in the patient’s medical records. 3. Duration of residency of at least 3 months in the present nursing home prior to enrolment into the study. 4. The patient’s The Functional Assessment Staging (FAST) is 5-6e (both inclusive) at screening. 5. The patient exhibits >0 score on the Neuropsychiatric Inventory – Nursing Home version (NPI-NH) sub-items 1, 2, or 3 (delusions, hallucinations, and agitation/aggression) at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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
Exclusion criteria
Exclusion criteria: 1. Patients with a DSM-IV Axis I disorder other than AD, including other primary causes of dementia, amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder. 2. Patients who are taking any unapproved concomitant medications according to the specified list in the protocol that cannot be discontinued. 3. Patients who have been previously treated with memantine within 6 months prior to entrance into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the specific effects of once daily dosing with memantine on behaviour, cognition, function, and global status as well as tolerability and safety in institutionalised patients with Alzheimer's Disease in a naturalistic setting.;Secondary Objective: To assess the benefit of the treatment on burden of care of the professional caregiver.;Primary end point(s): The efficacy variables will include: the Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGI-C) scores, the Ferm’s modified D-test (D-test) single items as well as the change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score and the single items, the Neuropsychiatric Inventory – Nursing Home version (NPI-NH) single items and psychosis cluster score (the sum of the single-item scores for delusions, hallucinations, and agitation /aggression), the NPI-NH occupational disruptiveness total score and the sum of the items corresponding to the psychosis cluster score, and the Boston Naming Test (BNT) total scores. | — |
Countries
Finland, United Kingdom
Outcome results
None listed