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A 12-Week Safety Extension Study of Oral ELND005

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: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

To evaluate the safety and tolerability of ELND005 treatment with up to 24 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 12-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:

U.S. FDA Resources

Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of ELND005 treatment with up to 24 weeks exposure, in Moderate to Severe AD patients with agitation and aggression. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Incidence and severity of TEAEs, SAEs, and withdrawals due to AEs. Incidence and severity of ARIA (ARIA-H and ARIA-E) on brain MRI at week 12 of Study AG251.


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (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 maintenance dose of 250 mg BID for 12 weeks.
 Drug: Group 1 ELND005
Pharmacologic and nonpharmacologic interventions (Risperdal Tablets, Liquid and Quicklet)
Experimental: Group 2 ELND005
Patients who received placebo during Study AG201: will receive a loading dose of ELND005 1000 mg BID for 4 weeks, followed by a maintenance dose of 250 mg BID for 8 weeks.
 Drug: Group 2 ELND005
Pharmacologic and nonpharmacologic interventions; (Risperdal tablets, Liquid, and Quicklet).

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complete Week 12 visit of AG201
  • Willing to remain off antipsychotic, anticonvulsant, and mood-stabilizing medications
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766336

Locations
United States, California
Elan Investigational Site
Long Beach, California, United States, 90806
United States, Georgia
Elan Investigational Site
Savannah, Georgia, United States, 31419
Sponsors and Collaborators
Elan Pharma International Limited
Elan Pharmaceuticals
  More 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
Study First Received: January 8, 2013
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Agitation
Aggression
AD patients

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013