Alzheimer's Disease Education and Referral Center

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 AgeMax AgeGenderHealthy Volunteers
50 Years
95 Years
Both
No
Inclusion Criteria: 
    • Diagnosis of probable Alzheimer's disease (MMSE score of 5 to 24 inclusive 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 the Elan Call Center at 1-866-395-2121.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.5075555, -86.8093239

Site
Birmingham
Alabama
35294
Recruiting
Name:
Phone:

Geolocation is 33.4528292, -112.0685027

Site
Phoenix
Arizona
85004
Recruiting
Name:
Phone:

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Recruiting
Name:
Phone:

Geolocation is 34.1583323, -118.5155901

Site
Encino
California
91316
Recruiting
Name:
Phone:

Geolocation is 33.090285, -117.0499859

Site
Escondido
California
92025
Recruiting
Name:
Phone:

Geolocation is 36.8179331, -119.7599761

Site
Fresno
California
93710
Recruiting
Name:
Phone:

Geolocation is 33.6471239, -117.8421325

Site
Irvine
California
92697
Recruiting
Name:
Phone:

Geolocation is 33.8065036, -118.1912538

Site
Long Beach
California
90806
Recruiting
Name:
Phone:

Geolocation is 33.8030716, -118.0725641

Site
Los Alamitos
California
90720
Recruiting
Name:
Phone:

Geolocation is 34.0522561, -118.452087

Site
Los Angeles
California
90073
Recruiting
Name:
Phone:

Geolocation is 33.615828, -117.9307584

Site
Newport Beach
California
92663
Recruiting
Name:
Phone:

Geolocation is 33.7463915, -117.8604472

Site
Santa Ana
California
92701
Recruiting
Name:
Phone:

Geolocation is 41.1339818, -73.4062342

Site
Norwalk
Connecticut
06851
Recruiting
Name:
Phone:

Geolocation is 38.9079086, -77.0716829

Site
Washington
District of Columbia
20057
Recruiting
Name:
Phone:

Geolocation is 26.5909025, -80.1008762

Site
Atlantis
Florida
33462
Recruiting
Name:
Phone:

Geolocation is 26.2778269, -80.109357

Site
Deerfield Beach
Florida
33064
Recruiting
Name:
Phone:

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Recruiting
Name:
Phone:

Geolocation is 26.5907805, -80.2432839

Site
Lake Worth
Florida
33449
Recruiting
Name:
Phone:

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Recruiting
Name:
Phone:

Geolocation is 26.180392, -80.1372757

Site
Oakland Park
Florida
33334
Recruiting
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting
Name:
Phone:

Geolocation is 29.2858129, -81.0558894

Site
Ormond Beach
Florida
32174
Recruiting
Name:
Phone:

Geolocation is 26.98699, -82.09518

Site
Port Charlotte
Florida
33952
Recruiting
Name:
Phone:

Geolocation is 27.4081935, -82.5294065

Site
Sarasota
Florida
34243
Recruiting
Name:
Phone:

Geolocation is 26.17785, -80.2711588

Site
Sunrise
Florida
33351
Recruiting
Name:
Phone:

Geolocation is 32.5371089, -84.9297206

Site
Columbus
Georgia
31909
Recruiting
Name:
Phone:

Geolocation is 31.9708128, -81.1586515

Site
Savannah
Georgia
31419
Recruiting
Name:
Phone:

Geolocation is 39.8264081, -89.6157473

Site
Springfield
Illinois
62702
Recruiting
Name:
Phone:

Geolocation is 44.8, -68.78

Site
Bangor
Maine
04402
Recruiting
Name:
Phone:

Geolocation is 38.7742826, -76.0763305

Site
Easton
Maryland
21601
Recruiting
Name:
Phone:

Geolocation is 42.452303, -71.1369959

Site
Winchester
Massachusetts
01890
Recruiting
Name:
Phone:

Geolocation is 42.2808256, -83.7430378

Site
Ann Arbor
Michigan
48105
Recruiting
Name:
Phone:

Geolocation is 42.2178171, -85.8911246

Site
Paw Paw
Michigan
49079
Recruiting
Name:
Phone:

Geolocation is 44.9737443, -93.0817473

Site
St. Paul
Minnesota
55130
Recruiting
Name:
Phone:

Geolocation is 31.3271189, -89.2903392

Site
Hattiesburg
Mississippi
39401
Recruiting
Name:
Phone:

Geolocation is 39.8267807, -75.0154461

Site
Stratford
New Jersey
08084
Recruiting
Name:
Phone:

Geolocation is 43.0915814, -77.6421577

Site
Rochester
New York
14623
Recruiting
Name:
Phone:

Geolocation is 43.1301942, -77.6020569

Site
Rochester
New York
14620
Recruiting
Name:
Phone:

Geolocation is 35.1811188, -80.8488498

Site
Charlotte
North Carolina
28209
Recruiting
Name:
Phone:

Geolocation is 35.1660032, -80.7934798

Site
Charlotte
North Carolina
28211
Recruiting
Name:
Phone:

Geolocation is 36.0038131, -78.9387241

Site
Durham
North Carolina
27710
Recruiting
Name:
Phone:

Geolocation is 34.2257255, -77.9447102

Site
Wilmington
North Carolina
28401
Recruiting
Name:
Phone:

Geolocation is 36.0564654, -80.3324514

Site
Winston-Salem
North Carolina
27103
Recruiting
Name:
Phone:

Geolocation is 35.5135639, -97.5788975

Site
Oklahoma City
Oklahoma
73112
Recruiting
Name:
Phone:

Geolocation is 45.5064511, -122.7756216

Site
Portland
Oregon
97225
Recruiting
Name:
Phone:

Geolocation is 40.1313817, -75.1370254

Site
Abington
Pennsylvania
19001
Recruiting
Name:
Phone:

Geolocation is 40.0959438, -75.1251743

Site
Jenkintown
Pennsylvania
19046
Recruiting
Name:
Phone:

Geolocation is 40.121497, -75.3399048

Site
Norristown
Pennsylvania
19401
Recruiting
Name:
Phone:

Geolocation is 39.9583587, -75.1953934

Site
Philadelphia
Pennsylvania
19104
Recruiting
Name:
Phone:

Geolocation is 39.9559288, -75.1574567

Site
Philadelphia
Pennsylvania
19107
Recruiting
Name:
Phone:

Geolocation is 40.4379259, -79.9556424

Site
Pittsburgh
Pennsylvania
15213
Recruiting
Name:
Phone:

Geolocation is 32.9221152, -80.0367259

Site
North Charleston
South Carolina
29406
Recruiting
Name:
Phone:

Geolocation is 32.379494, -80.6937177

Site
Port Royal
South Carolina
29935
Recruiting
Name:
Phone:

Geolocation is 36.1390165, -86.7969244

Site
Nashville
Tennessee
37212
Recruiting
Name:
Phone:

Geolocation is 32.5898577, -96.8569451

Site
DeSoto
Texas
75115
Recruiting
Name:
Phone:

Geolocation is 37.5803608, -77.4874049

Site
Richmond
Virginia
23230
Recruiting
Name:
Phone:

Geolocation is 47.6105427, -122.142426

Site
Bellevue
Washington
98007
Recruiting
Name:
Phone:

Geolocation is 51.0662767, -114.1355032

Site
Calgary
Alberta
T2N-4Z6
Recruiting
Name:
Phone:

Geolocation is 49.8847057, -119.4765266

Site
Kelowna
British Columbia
V1Y 3G8
Recruiting
Name:
Phone:

Geolocation is 43.698592, -79.4751345

Site
Toronto
Ontario
M6M 3Z5
Recruiting
Name:
Phone:

Geolocation is 43.7215696, -79.3768256

Site
Toronto
Ontario
M4N 3M5
Recruiting
Name:
Phone:

Geolocation is 50.4542964, -104.6381398

Site
Regina
Saskatchewan
S4T 1A5
Recruiting
Name:
Phone:
Lead Sponsor: 
Agency
Elan Pharmaceuticals
Collaborator Sponsor: 
Agency
Elan Pharmaceuticals
Facility Investigators: 
Study Contact: 
NamePhone
Elan Call Center
1-866-395-2121
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
Disease Stage: 
Early
Middle
Late
Enrollment: 
400