Alzheimer's Disease Education and Referral Center

Lu AE58054 in People with Mild to Moderate Alzheimer's Disease Taking Donepezil

Lu AE58054 in People with Mild to Moderate Alzheimer's Disease Taking Donepezil

Overall Status: 
Recruiting
Brief Description: 

This clinical trial will test the experimental drug Lu AE58054 as an add-on therapy to donepezil for people with mild to moderate Alzheimer's disease.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
N/A
Both
No
Inclusion Criteria: 
    • Knowledgeable, reliable caregiver
    • Probable mild to moderate Alzheimer's disease
    • Stable treatment with donepezil (Aricept®)
    • If female, must have had last natural menstruation at least 2 years before screening or be surgically sterile; if male, must agree to use effective contraception if female partner is of childbearing potential or be surgically sterile
Exclusion Criteria: 
    • Evidence of clinically significant neurodegenerative disease or serious neurological disorders other than Alzheimer's disease
    • Axis I disorder other than Alzheimer's disease, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision
    • Evidence of any other clinically significant disease
    • Likely interruption or discontinuation of donepezil therapy during the study
    • Currently taking memantine or has taken memantine within 2 months prior to screening
Detailed Description: 

In this Phase III trial, participants taking 10 mg of donepezil will be assigned to take either the study drug, Lu AE58054, or a placebo as a tablet once daily. Tests of cognition, daily functioning, and behavior will be conducted. Lu AE58054 is a selective 5HT6 receptor antagonist with a different mechanism of action than currently available Alzheimer's medications. In past studies, it has helped improve cognition by acting on brain regions involved in cognition, such as the cortex and the hippocampus, and modulating the activity of multiple neurotransmitter systems.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.5206608, -86.80249

Site
Birmingham
Alabama
Recruiting
Name:
Phone:

Geolocation is 33.4483771, -112.0740373

Site
Phoenix
Arizona
Recruiting
Name:
Phone:

Geolocation is 34.7464809, -92.2895948

Site
Little Rock
Arkansas
Recruiting
Name:
Phone:

Geolocation is 32.8475528, -115.5694391

Site
Imperial
California
Recruiting
Name:
Phone:

Geolocation is 33.7700504, -118.1937395

Site
Long Beach
California
Recruiting
Name:
Phone:

Geolocation is 34.0522342, -118.2436849

Site
Los Angeles
California
Recruiting
Name:
Phone:

Geolocation is 32.715738, -117.1610838

Site
San Diego
California
Recruiting
Name:
Phone:

Geolocation is 33.7455731, -117.8678338

Site
Santa Ana
California
Recruiting
Name:
Phone:

Geolocation is 27.4989278, -82.5748194

Site
Bradenton
Florida
Recruiting
Name:
Phone:

Geolocation is 28.5383355, -81.3792365

Site
Orlando
Florida
Recruiting
Name:
Phone:

Geolocation is 26.9761707, -82.0906448

Site
Port Charlotte
Florida
Recruiting
Name:
Phone:

Geolocation is 33.7489954, -84.3879824

Site
Atlanta
Georgia
Recruiting
Name:
Phone:

Geolocation is 21.4022222, -157.7394444

Site
Kailua
Hawaii
Recruiting
Name:
Phone:

Geolocation is 41.8781136, -87.6297982

Site
Chicago
Illinois
Recruiting
Name:
Phone:

Geolocation is 39.768403, -86.158068

Site
Indianapolis
Indiana
Recruiting
Name:
Phone:

Geolocation is 43.8570065, -70.1031201

Site
Freeport
Maine
Recruiting
Name:
Phone:

Geolocation is 42.3370413, -71.2092214

Site
Newton
Massachusetts
Recruiting
Name:
Phone:

Geolocation is 42.2917069, -85.5872286

Site
Kalamazoo
Michigan
Recruiting
Name:
Phone:

Geolocation is 32.3095903, -90.1389757

Site
Flowood
Mississippi
Recruiting
Name:
Phone:

Geolocation is 40.9259319, -74.6348828

Site
Mount Arlington
New Jersey
Recruiting
Name:
Phone:

Geolocation is 39.9537358, -74.1979458

Site
Toms River
New Jersey
Recruiting
Name:
Phone:

Geolocation is 39.9537358, -74.1979458

Site
Toms River
New Jersey
Recruiting
Name:
Phone:

Geolocation is 42.9756133, -78.7914222

Site
Amherst
New York
Recruiting
Name:
Phone:

Geolocation is 40.7706572, -73.7176312

Site
Lake Success
New York
Recruiting
Name:
Phone:

Geolocation is 40.7978787, -73.6995749

Site
Manhasset
New York
Recruiting
Name:
Phone:

Geolocation is 40.7127837, -74.0059413

Site
New York
New York
Recruiting
Name:
Phone:

Geolocation is 41.0470911, -73.9475931

Site
Old Orangeburg
New York
Recruiting
Name:
Phone:

Geolocation is 39.6283928, -84.1593818

Site
Centerville
Ohio
Recruiting
Name:
Phone:

Geolocation is 39.9611755, -82.9987942

Site
Columbus
Ohio
Recruiting
Name:
Phone:

Geolocation is 45.5230622, -122.6764816

Site
Portland
Oregon
Recruiting
Name:
Phone:

Geolocation is 43.0730517, -89.4012302

Site
Madison
Wisconsin
Recruiting
Name:
Phone:

Geolocation is 43.0389025, -87.9064736

Site
Milwaukee
Wisconsin
Recruiting
Name:
Phone:

Geolocation is 45.4765446, -75.7012723

Site
Gatineau
None
Recruiting
Name:
Phone:

Geolocation is 51.5073509, -0.1277583

Site
London
None
Recruiting
Name:
Phone:

Geolocation is 44.059187, -79.461256

Site
Newmarket
None
Recruiting
Name:
Phone:

Geolocation is 43.653226, -79.3831843

Site
Toronto
None
Recruiting
Name:
Phone:

Geolocation is 43.653226, -79.3831843

Site
Toronto
None
Recruiting
Name:
Phone:
Lead Sponsor: 
Agency
H. Lundbeck A/S
Collaborator Sponsor: 
Agency
Otsuka Pharmaceutical Co., Ltd.
Facility Investigators: 
NameRoleAffiliation
H. Lundbeck A/S
Study Director
LundbeckClinicalTrials@lundbeck.com
Study Contact: 
NameEmail
H. Lundbeck A/S
Locations
 
 
ClinicalTrials.gov ID 
NCT01955161 (follow link to view full record on ct.gov in new window)
Official Title: 
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Study Start Date: 
October 2013
Study End Date: 
September 2015
Disease Stage: 
Early
Middle
Enrollment: 
930