Study TypeAlzheimer's Disease
Study PurposeThe purpose of this research study is to test the safety and effectiveness of the investigational drug EVP-6124 in the treatment of subjects with mild to moderate dementia due to Alzheimer's disease.
About the Study
Alzheimer's disease (AD) is the leading cause of dementia in the elderly. The prevalence of dementia in those ≥65 years in North America is approximately 6 to 10%, with AD accounting for approximately 66% of these cases. This illness represents a steadily growing medical and social problem of our aging societies.
The EVAD study is designed to provide additional evidence of the safety, tolerability, and cognitive effects of EVP-6124 in subjects with mild to moderate dementia due to AD currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor (AChEI) (donepezil, rivastigmine, or galantamine).
- 2 Screening visits
- 7 Clinic visits
- 1 Follow-up clinic visit
- Telephone calls throughout the study
- Height, weight, vitals, physical exam
- Electrocardiogram (ECG)
- Urinalysis and blood draws
- EVP-6124 2mg once a day
- EVP-6124 3mg once a day
- Placebo once a day
Number of visits:
Eligible participants will be assigned by chance to one of the following treatment groups:
- Age: 55-85 years old
- Clinical diagnosis of dementia due to probable AD consistent with criteria established by a workgroup of the National Institute on Aging and the Alzheimer's Disease Association
- You have a clear history of cognitive and functional decline over at least one year that is either documented in medical records or documented by report from an informant who knows you well.