Alzheimer Disease
Conditions
Keywords
Alzheimer's disease, symptomatic, cognition
Brief summary
Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill). Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.
Interventions
DRUGAVE1625
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The diagnosis of Alzheimer's disease * Recent brain image(Computerized Axial Tomographic Scan -CAT scan or Magnetic Resonance Imaging - MRI) * Mild to moderate range of disease; not too severe
Exclusion criteria
* Severe or unstable medical diseases * Neurological disorder other than Alzheimer's disease * Depression that is not well controlled * Treatment with memantine * Inpatient in a total care facility (e.g.: Nursing home) * Lack of reliable caregiver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability throughout the study:adverse events collected by spontaneous report | — |
| physical examination and neurological assessment | — |
| vital sign monitoring, clinical laboratories, and ECGs. | — |
| Efficacy variables:measures of change in cognition, global functioning and behavior at week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters will be assessed throughout the 12-week treatment period. | — |
Countries
France, Italy, Netherlands, Sweden, United States
Outcome results
None listed