An Open-Label Study Investigating the Specific Effects of Memantine in Institutionalised Patients with Alzheimer’s Disease - NA

Phase 1

• Conditions: Effects of memantine treatment in institutionalised patients with Alzheimer's Disease.

• Registration Number: EUCTR2006-000860-10-BE
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-18
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 175

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

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.

Study & Design

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