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 32.8475528, -115.5694391

Site
Imperial
California
92251
Recruiting
Name:
Phone:

Geolocation is 33.7455731, -117.8678338

Site
Santa Ana
California
92705
Recruiting
Name:
Phone:

Geolocation is 27.4872771, -82.5889012

Site
Bradenton
Florida
34205
Recruiting
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting
Name:
Phone:

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Recruiting
Name:
Phone:

Geolocation is 43.8570065, -70.1031201

Site
Freeport
Maine
04032
Recruiting
Name:
Phone:

Geolocation is 42.9674726, -78.7986181

Site
Amherst
New York
14226
Recruiting
Name:
Phone:

Geolocation is 40.7978787, -73.6995749

Site
Manhasset
New York
11030
Recruiting
Name:
Phone:

Geolocation is 39.6400784, -84.1751648

Site
Centerville
Ohio
45459
Recruiting
Name:
Phone:

Geolocation is 43.7585342, -79.3535081

Site
Toronto
None
M3B 2S7
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