Alzheimer's Disease Clinical Trial
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
| Verified date | October 2019 |
| Source | OPKO Health, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 296 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 95 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | TransitionTIL Investigational Site | Toronto | Ontario |
| Spain | TransitionTIL Investigational Site | Barcelona | |
| Spain | TransitionTIL Investigational Site | Elche | Alicante |
| Spain | TransitionTIL Investigational Site | Madrid | |
| Spain | TransitionTIL Investigational Site | Terrassa | Barcelona |
| United Kingdom | TransitionTIL Investigational Site | Swindon | Wiltshire |
| United States | TransitionTIL Investigational Site | Abington | Pennsylvania |
| United States | TransitionTIL Investigational Site | Atlantis | Florida |
| United States | TransitionTIL Investigational Site | Bellevue | Washington |
| United States | TransitionTIL Investigational Site | Birmingham | Alabama |
| United States | TransitionTIL Investigational Site | Charlotte | North Carolina |
| United States | TransitionTIL Investigational Site | Columbus | Georgia |
| United States | TransitionTIL Investigational Site | Deerfield Beach | Florida |
| United States | TransitionTIL Investigational Site | Delray Beach | Florida |
| United States | TransitionTIL Investigational Site | DeSoto | Texas |
| United States | TransitionTIL Investigational Site | Durham | North Carolina |
| United States | TransitionTIL Investigational Site | Easton | Maryland |
| United States | TransitionTIL Investigational Site | Encino | California |
| United States | TransitionTIL Investigational Site | Escondido | California |
| United States | TransitionTIL Investigational Site | Fresno | California |
| United States | TransitionTIL Investigational Site | Jenkintown | Pennsylvania |
| United States | TransitionTIL Investigational Site | Lake Worth | Florida |
| United States | TransitionTIL Investigational Site | Long Beach | California |
| United States | TransitionTIL Investigational Site | Newport Beach | California |
| United States | TransitionTIL Investigational Site | Norristown | Pennsylvania |
| United States | TransitionTIL Investigational Site | Norwalk | Connecticut |
| United States | TransitionTIL Investigational Site | Oakland Park | Florida |
| United States | TransitionTIL Investigational Site | Oklahoma City | Oklahoma |
| United States | TransitionTIL Investigational Site | Orange | California |
| United States | TransitionTIL Investigational Site | Orlando | Florida |
| United States | TransitionTIL Investigational Site | Phoenix | Arizona |
| United States | TransitionTIL Investigational Site | Phoenix | Arizona |
| United States | TransitionTIL Investigational Site | Pittsburgh | Pennsylvania |
| United States | TransitionTIL Investigational Site | Port Charlotte | Florida |
| United States | TransitionTIL Investigational Site | Port Royal | South Carolina |
| United States | TransitionTIL Investigational Site | Portland | Oregon |
| United States | TransitionTIL Investigational Site | Rochester | New York |
| United States | TransitionTIL Investigational Site | Rochester | New York |
| United States | TransitionTIL Investigational Site | Saint Paul | Minnesota |
| United States | TransitionTIL Investigational Site | Sarasota | Florida |
| United States | TransitionTIL Investigational Site | Savannah | Georgia |
| United States | TransitionTIL Investigational Site | Springfield | Illinois |
| United States | TransitionTIL Investigational Site | Washington | District of Columbia |
| United States | TransitionTIL Investigational Site | Wilmington | North Carolina |
| United States | TransitionTIL Investigational Site | Winchester | Massachusetts |
| United States | TransitionTIL Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| OPKO Health, Inc. | Elan Pharmaceuticals |
United States, Canada, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Experiencing Treatment Emergent Adverse Events | 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. | 36 weeks |
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