Prodromal Alzheimer's Disease
Conditions
Interventions
Product Name: MK-8931
Product Code: MK-8931
Pharmaceutical Form: Tablet
INN or Proposed INN: MK-8931
Current Sponsor code: MK-8931, SCH
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Have tolerated study medication and completed the initial 104-week trial. Subjects who did not complete the initial 104-weeks of treatment but continued with and completed scheduled visits may be permitted to continue in the long term extension at the discretion of the Sponsor. Subjects who repeatedly deviate from protocol requirements will not be permitted to continue in this extension. In addition, subjects who are less than 75% compliant with trial medication during the initial 104-week trial will not be permitted to continue in the long term safety extension, except in special circumstances, which require Sponsor approval. -Have a trial partner who is reliable and competent. The trial partner must have a close relationship with the subject, have face to face contact at least 3 days/week for a minimum of 6 waking hours/week (or more, based on local requirements), be willing to accompany the subject to all trial visits, and be willing to monitor compliance of the administration of the trial medication. The trial partner should understand the nature of the trial and adhere to trial requirements (e.g. dose, visit scheduled and evaluations). It is recommended that the trial partner accompany the subject to all trial visits. -Sign (or legal representative signature) the informed consent in accordance with local requirements, after the scope and nature of the trial have been explained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 236 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 709
Exclusion criteria
Exclusion criteria: -Is in imminent risk of self harm, based on clinical interview or on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Subjects who report suicidal ideation with intent, with or without a plan (e.g., suicidal ideation item 4 or 5 on the C-SSRS) in the past one (1) month or suicidal behavior in the past six (6) months should be excluded. Such subjects will be permitted to rescreen for entry into this study once in the Investigator?s opinion, this risk of harm to self or others is no longer present. -Has developed a recent or ongoing, uncontrolled, clinically significant medical or psychiatric condition that precludes participation in this protocol in the judgment of the investigator. -Based on results from the EOT Visit (Visit 12) in the initial 104-week trial has results of clinical laboratory tests (complete blood count [CBC], blood chemistries, and urinalysis) that are clinically unacceptable to the investigator. -Based on the results from the EOT Visit (Visit 12) has results of a physical examination, and vital signs that are clinically unacceptable to the investigator. -Has developed a form of dementia that is not Alzheimer's disease, including but not limited to, dementia due to HIV infection, head trauma, vascular disease, Parkinson's disease, frontotemporal dementia, or Huntington's disease, as determined by the investigator. -Anticipates receiving any of the treatments listed as prohibited.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -There are no secondary objectives for this long term safety trial.;Primary end point(s): The primary endpoint is the change from baseline (CFB) in CDR-SB score at Week 130.;Timepoint(s) of evaluation of this end point: Baseline and Week 130.; Main Objective: -To evaluate the safety and tolerability of MK-8931 in the long term treatment of prodromal Alzheimer?s Disease (AD) -To compare the efficacy of MK-8931 administered to subjects for 30 months to that of subjects administered placebo for 24 months followed by MK-8931 for 6 months using the change from baseline score CDR-SB score at Week 130. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactInvestigación Clínica
Merck Sharp & Dohme de España S.A.
Outcome results
None listed