Fluency (oral and written) in English or Spanish.General health status acceptable for participation in the study.Patient living at home, senior residential setting, or an institutional setting without the need for continuous (i.e.If female, postmenopausal for at least 1 year.Clinical diagnosis of dementia due to possible or probable AD consistent with criteria established by a workgroup of the National Institute on Aging and the Alzheimer's Disease Association.Patient has a caregiver or legal representative responsible for administering the drug and recording the time.Informed consent form (ICF) signed by the subject or legally acceptable representative.Matching placebo for the 6-month randomized period (Month 12 to Month 18)Ī 12-Month, Open-Label Safety Study of Simufilam Followed by a 6-Month Randomized Withdrawal and 6 Additional Months Open-Label in Mild-to-moderate Alzheimer's Disease Patients Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) At Month 18, all participants will enter a final 6-month treatment period of open-label simufilam 100 mg b.i.d. or to be switched to placebo for 6 months.
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At Month12, participants will be randomized (1:1) to continue taking simufilam 100 mg b.i.d. All participants will receive open-label simufilam 100 mg b.i.d. Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More InformationĪpproximately two hundred (200) patients will be enrolled into the study. Why Should I Register and Submit Results?.