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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 has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766336
First Posted: January 11, 2013
Last Update Posted: June 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
January 8, 2013
January 11, 2013
April 7, 2016
May 13, 2016
June 22, 2016
January 2013
August 2015   (Final data collection date for primary outcome measure)
Number of Participants Experiencing Treatment Emergent Adverse Events [ Time Frame: 36 weeks ]
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.
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 ]
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
Not Provided
Not Provided
Not Provided
Not Provided
 
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 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Group 1 ELND005
  • Drug: Group 2 ELND005
  • Experimental: Group 1 ELND005/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 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.
    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.
 
Terminated
296
August 2015
August 2015   (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
Sexes Eligible for Study: All
50 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Spain,   United Kingdom,   United States
 
 
NCT01766336
ELND005-AG251
2012-005524-15 ( EudraCT Number )
No
Not Provided
Not Provided
Transition Therapeutics Ireland Limited
Transition Therapeutics Ireland Limited
Elan Pharmaceuticals
Not Provided
Transition Therapeutics Ireland Limited
May 2016

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