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

NCT ID: NCT01766336

Last Updated: 2019-10-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1 ELND005/ELND005

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

Group Type EXPERIMENTAL

Group 1 ELND005

Intervention Type DRUG

Group 2 PLACEBO/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.

Group Type EXPERIMENTAL

Group 2 ELND005

Intervention Type DRUG

Interventions

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Group 1 ELND005

Intervention Type DRUG

Group 2 ELND005

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elan Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

OPKO Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TransitionTIL Investigational Site

Birmingham, Alabama, United States

Site Status

TransitionTIL Investigational Site

Phoenix, Arizona, United States

Site Status

TransitionTIL Investigational Site

Phoenix, Arizona, United States

Site Status

TransitionTIL Investigational Site

Encino, California, United States

Site Status

TransitionTIL Investigational Site

Escondido, California, United States

Site Status

TransitionTIL Investigational Site

Fresno, California, United States

Site Status

TransitionTIL Investigational Site

Long Beach, California, United States

Site Status

TransitionTIL Investigational Site

Newport Beach, California, United States

Site Status

TransitionTIL Investigational Site

Orange, California, United States

Site Status

TransitionTIL Investigational Site

Norwalk, Connecticut, United States

Site Status

TransitionTIL Investigational Site

Washington D.C., District of Columbia, United States

Site Status

TransitionTIL Investigational Site

Atlantis, Florida, United States

Site Status

TransitionTIL Investigational Site

Deerfield Beach, Florida, United States

Site Status

TransitionTIL Investigational Site

Delray Beach, Florida, United States

Site Status

TransitionTIL Investigational Site

Lake Worth, Florida, United States

Site Status

TransitionTIL Investigational Site

Oakland Park, Florida, United States

Site Status

TransitionTIL Investigational Site

Orlando, Florida, United States

Site Status

TransitionTIL Investigational Site

Port Charlotte, Florida, United States

Site Status

TransitionTIL Investigational Site

Sarasota, Florida, United States

Site Status

TransitionTIL Investigational Site

Columbus, Georgia, United States

Site Status

TransitionTIL Investigational Site

Savannah, Georgia, United States

Site Status

TransitionTIL Investigational Site

Springfield, Illinois, United States

Site Status

TransitionTIL Investigational Site

Easton, Maryland, United States

Site Status

TransitionTIL Investigational Site

Winchester, Massachusetts, United States

Site Status

TransitionTIL Investigational Site

Saint Paul, Minnesota, United States

Site Status

TransitionTIL Investigational Site

Rochester, New York, United States

Site Status

TransitionTIL Investigational Site

Rochester, New York, United States

Site Status

TransitionTIL Investigational Site

Charlotte, North Carolina, United States

Site Status

TransitionTIL Investigational Site

Durham, North Carolina, United States

Site Status

TransitionTIL Investigational Site

Wilmington, North Carolina, United States

Site Status

TransitionTIL Investigational Site

Winston-Salem, North Carolina, United States

Site Status

TransitionTIL Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

TransitionTIL Investigational Site

Portland, Oregon, United States

Site Status

TransitionTIL Investigational Site

Abington, Pennsylvania, United States

Site Status

TransitionTIL Investigational Site

Jenkintown, Pennsylvania, United States

Site Status

TransitionTIL Investigational Site

Norristown, Pennsylvania, United States

Site Status

TransitionTIL Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

TransitionTIL Investigational Site

Port Royal, South Carolina, United States

Site Status

TransitionTIL Investigational Site

DeSoto, Texas, United States

Site Status

TransitionTIL Investigational Site

Bellevue, Washington, United States

Site Status

TransitionTIL Investigational Site

Toronto, Ontario, Canada

Site Status

TransitionTIL Investigational Site

Elche, Alicante, Spain

Site Status

TransitionTIL Investigational Site

Terrassa, Barcelona, Spain

Site Status

TransitionTIL Investigational Site

Barcelona, , Spain

Site Status

TransitionTIL Investigational Site

Madrid, , Spain

Site Status

TransitionTIL Investigational Site

Swindon, Wiltshire, United Kingdom

Site Status

Countries

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United States Canada Spain United Kingdom

Other Identifiers

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2012-005524-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ELND005-AG251

Identifier Type: -

Identifier Source: org_study_id

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