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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

January 8, 2013
July 3, 2014
January 2013
February 2016   (final data collection date for primary outcome measure)
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.
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 severuty of ARIA (ARIA-H and ARIA-E) on brain MRI at week 12 of Study AG251.
Complete list of historical versions of study NCT01766336 on ClinicalTrials.gov Archive Site
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A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Group 1 ELND005
  • Drug: Group 2 ELND005
  • Experimental: Group 1 ELND005
    Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks.
    Intervention: 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.
    Intervention: Drug: Group 2 ELND005
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
Not Provided
February 2016   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Spain,   United Kingdom
 
NCT01766336
ELND005-AG251, 2012-005524-15
No
Elan Pharmaceuticals ( Elan Pharma International Limited )
Elan Pharma International Limited
Elan Pharmaceuticals
Not Provided
Elan Pharmaceuticals
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP