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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier:
NCT01766336
First received: January 8, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

To evaluate the safety and tolerability of ELND005 treatment with up to 48 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.


Condition Intervention Phase
Alzheimer's Disease
Drug: Group 1 ELND005
Drug: Group 2 ELND005
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of ELND005 treatment with up to 48 weeks exposure, in Moderate to Severe AD patients with agitation and aggression. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Incidence and severity of TEAEs, SAEs, and withdrawals due to AEs.


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 ELND005
Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks.
Drug: Group 1 ELND005
Experimental: Group 2 ELND005
Patients who received placebo during Study AG201 will receive ELND005 at a dose similar to the active group in Study AG201 for 36 weeks.
Drug: Group 2 ELND005

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766336

  Show 46 Study Locations
Sponsors and Collaborators
Elan Pharma International Limited
Elan Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier: NCT01766336     History of Changes
Other Study ID Numbers: ELND005-AG251, 2012-005524-15
Study First Received: January 8, 2013
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Agitation
Aggression
AD patients

Additional relevant MeSH terms:
Aggression
Alzheimer Disease
Psychomotor Agitation
Behavioral Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014