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

Phase 2TerminatedNCT01766336

OPKO Health, Inc.296 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

296

Conditions

Alzheimer's Disease

Interventions

Group 1 ELND005DRUG

Group 2 ELND005DRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

Number of Participants Experiencing Treatment Emergent Adverse Events

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.

Time frame: 36 weeks

Data from ClinicalTrials.gov

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