A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
Phase 2
Terminated
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: Group 1 ELND005Drug: Group 2 ELND005
- Registration Number
- NCT01766336
- Lead Sponsor
- OPKO Health, Inc.
- Brief Summary
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 296
Inclusion Criteria
- Complete Week 12 visit of AG201
- Both patient and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests
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
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 ELND005/ELND005 Group 1 ELND005 Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks. Group 2 PLACEBO/ELND005 Group 2 ELND005 Patients who received placebo during Study AG201 will receive ELND005 at the same dosing regimen as the active group in Study AG201 for 36 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Treatment Emergent Adverse Events 36 weeks To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
TransitionTIL Investigational Site
🇬🇧Swindon, Wiltshire, United Kingdom