A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

OPKO Health

Status and phase: Terminated; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Group 1 ELND005; Drug: Group 2 ELND005

Study type: Interventional

Funder types: Industry

Identifiers

NCT01766336

ELND005-AG251

2012-005524-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 296 patients

Sex: All

Ages: 50 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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296 participants in 2 patient groups

Group 1 ELND005/ELND005

Experimental group

Description:

Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks.

Treatment:

Drug: Group 1 ELND005

Group 2 PLACEBO/ELND005

Experimental group

Description:

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.

Treatment:

Drug: Group 2 ELND005