ELND005 for Agitation and Aggression in Alzheimer's Disease
ELND005 for Agitation and Aggression in Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
The purpose of this study is to determine whether the experimental drug ELND005 is effective in treating symptoms of agitation and aggression in people with Alzheimer's disease.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 85 Years | Both | No |
Inclusion Criteria:
- Diagnosis of probable Alzheimer's disease (MMSE score of 10 to 21 at screening)
- Clinically significant agitation/aggression, defined as Neuropsychiatric Inventory (NPI) agitation/aggression subscore of ≥4, with a severity score of ≥2 at both screening and baseline visits
- No response or suboptimal response to standard nonpharmacological interventions
Exclusion Criteria:
- Agitation/aggression attributable to medications, environmental conditions, or an active medical or psychiatric condition
- Current diagnosis of major depressive disorder
- Symptoms of psychosis (delusion or hallucinations) that require treatment with antipsychotics or psychiatric hospitalization
- Treated with oral antipsychotic medications within 2 weeks prior to screening; treated with depot preparations of an antipsychotic within 3 months prior to screening
- MRI scan abnormalities at screening that can be attributed to diseases or processes other than Alzheimer's disease
Detailed Description:
The experimental drug being tested in this Phase II study, ELDN005, is a small molecule that has been found to block the accumulation of beta-amyloid oligomers and possibly protect against cognitive decline. Known generically as scyllo-inositol, it is a naturally occurring plant sugar alcohol found in the coconut palm, oak bark, and other plants.
Central Contact Information:
For more information about this trial or its study sites, please contact Barbara Gaunce at 910-558-4645.
Locations:
| Map Marker | City | State | Zip Code | Status | |
|---|---|---|---|---|---|
Geolocation is 33.4528292, -112.0685027 | Site | Phoenix | Arizona | 85004 | Recruiting |
Geolocation is 33.612697, -112.280129 | Site | Sun City | Arizona | 85351 | Recruiting |
Geolocation is 34.1583323, -118.5155901 | Site | Encino | California | 91316 | Recruiting |
Geolocation is 33.090285, -117.0499859 | Site | Escondido | California | 92025 | Recruiting |
Geolocation is 33.8065036, -118.1912538 | Site | Long Beach | California | 90806 | Recruiting |
Geolocation is 33.8030716, -118.0725641 | Site | Los Alamitos | California | 90720 | Recruiting |
Geolocation is 41.1339818, -73.4062342 | Site | Norwalk | Connecticut | 06851 | Recruiting |
Geolocation is 26.4647478, -80.109357 | Site | Delray Beach | Florida | 33445 | Recruiting |
Geolocation is 25.8207159, -80.1819268 | Site | Miami | Florida | 33137 | Recruiting |
Geolocation is 28.5085825, -81.3564411 | Site | Orlando | Florida | 32806 | Recruiting |
Geolocation is 26.8598894, -80.0870155 | Site | Palm Beach Gardens | Florida | 33410 | Recruiting |
Geolocation is 27.4081935, -82.5294065 | Site | Sarasota | Florida | 34243 | Recruiting |
Geolocation is 26.17785, -80.2711588 | Site | Sunrise | Florida | 33351 | Recruiting |
Geolocation is 31.9708128, -81.1586515 | Site | Savannah | Georgia | 31419 | Recruiting |
Geolocation is 42.0039178, -87.9703461 | Site | Elk Grove Village | Illinois | 60007 | Recruiting |
Geolocation is 40.3572976, -74.6672226 | Site | Princeton | New Jersey | 08540 | Recruiting |
Geolocation is 36.0564654, -80.3324514 | Site | Winston-Salem | North Carolina | 27103 | Recruiting |
Geolocation is 35.5135639, -97.5788975 | Site | Oklahoma City | Oklahoma | 73112 | Recruiting |
Geolocation is 40.0959438, -75.1251743 | Site | Jenkintown | Pennsylvania | 19046 | Recruiting |
Geolocation is 32.5898577, -96.8569451 | Site | DeSoto | Texas | 75115 | Recruiting |
Geolocation is 47.6105427, -122.142426 | Site | Bellevue | Washington | 98007 | Recruiting |
Geolocation is 44.3073347, -78.3218108 | Site | Peterborough | Ontario | K9H 2P4 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Elan Pharmaceuticals |
Collaborator Sponsor:
| Agency |
|---|
Elan Pharmaceuticals |
Facility Investigators:
Study Contact:
| Name | Phone |
|---|---|
Barbara Gaunce | 910-558-4645 |
Locations
ClinicalTrials.gov ID
NCT01735630 (follow link to view full record on ct.gov in new window)
Official Title:
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
Study Start Date:
November 2012
Study End Date:
December 2013
Disease Stage:
Early
Middle
Late
Enrollment:
400
