A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease.

Phase 1

Conditions: Agitation and Aggression in Moderate to severe Alzheimer's Disease.
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-005524-15-GB

Lead Sponsor: Elan Pharma International Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

- Signed and dated written informed consent obtained in accordance with local regulations.
- Completes the Week 12 visit in study AG201 while taking their assigned does of study drug.
- Has no new medical condtraindication to continue participation in the study
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

-Is currently using any other investigational or experimental drugs or devices.
- Has significant worsening of medical conditions or dementia such that it may preclude completion of this safety extension study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To evaluate additional efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) endpoints.;Primary end point(s): Safety Endpoints:<br>-Incident and severty of treatment-emergent AEs, serious AEs, and withdrawls due to AEs.<br><br>-Changes in Baseline of Study AG201 to Week 36 of Study AG251 in the following safety assesments: vital sign measurments, weight, clinical laboratory assessments, physical and neurological examinations, and ECGs.;Timepoint(s) of evaluation of this end point: Week 36;Main Objective: To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure (or up to 48 weeks across studies AG201 and AG251), in Moderate to Severe Alzheimer's Disease patients with agitation and aggression.<br>To evaluate the effects and persistence of effects of ELND005 on agitation and aggression and other assesments including neuropsychiatric symptons, cognitive status, patient's dependence status and caregiver distress.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy endpoints:<br>Changes in baseline to Week 36 in Study AG251 (for all patients), and changes from baseline in Study AG201 to Week 36 of Study AG251 (for patients in Group 1) in:<br>-NPI-C combined agitation and aggression subscores<br>-mADCS-CGIC agitation domain scores (CGIC)<br>-NPI-C subitems of agitation, aggression, apathy, depression/dysphoria, anxiety.<br>-NPI subitems of aberrant motor behaviour, nighttime behavior, disinhibition, delusions and hallucinations.<br>-Total NPI score.<br><br>PK/PD Assessments/Endpoints<br>Relationship between PK parmaeters and selected safety, efficacy, and PD outcome measures.;Timepoint(s) of evaluation of this end point: Week 36