A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT01766336|
Recruitment Status : Terminated
First Posted : January 11, 2013
Results First Posted : May 13, 2016
Last Update Posted : June 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Group 1 ELND005 Drug: Group 2 ELND005||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||296 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2013|
|Primary Completion Date :||August 2015|
|Study Completion Date :||August 2015|
Experimental: Group 1 ELND005/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 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.
|Drug: Group 2 ELND005|
- 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 learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766336
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