Alzheimer Disease, Dementia
Conditions
Keywords
Alzheimer Disease, Dementia
Brief summary
This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. Study subjects will have the diagnosis of mild dementia of the Alzheimer's type. Subjects may be taking approved medication for Alzheimer's disease provided the dose has been stable for at least 6 months.
Interventions
DRUGMPC-7869
Oral 800 mg BID
Sponsors
Myrexis Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have had a diagnosis of probable Alzheimer's disease 2. Men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility). 3. Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study. 4. Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures. 5. At least 6 years of education, or sufficient work history to exclude mental retardation. 6. Female subjects must be surgically sterile or postmenopausal for \> 1 year. 7. Adequate vision and hearing to participate in study assessments. 8. Subjects must have a reliable caregiver who can read, understand and speak same language.
Exclusion criteria
1. Current evidence of other causes of dementia.. . 2. History of, or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor. 3. Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening. 4. Major surgery and related complications not resolved within 12 weeks prior to Day 1. 5. Previous participation in an MPC-7869 clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition and activities of daily living | 18 mos |
Secondary
| Measure | Time frame |
|---|---|
| Global function and cognition | 18 months |
Countries
Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed