Alzheimer Disease
Conditions
Brief summary
The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.
Interventions
DRUGlecozotan SR
evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil.
DRUGDonepezil
10 mg donepezil QD dosed up to 40 weeks
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of probable AD according to the NINCDS-ADRDA criteria. * Able to give informed consent. Patient' s caregiver must consent to participate in the study.
Exclusion criteria
* Use of medications for cognitive enhancement within 3 months of baseline. * Significant neurologic disease other than AD that may affect cognition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score. | weeks 12, 14, 26 and 40. |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures. | weeks 12, 14, 26 and 40. |
Countries
Argentina, Australia, Canada, South Africa, United States
Outcome results
None listed