Participants with Early Alzheimer’s Disease
If you’re a caregiver considering joining a clinical trial, you’ll want to have a plan beforehand. Planning your visits ahead will help your loved one remain consistent over time. It’ll also help you determine whether or not there’s enough time to maintain the increasing demands of dementia.
Find A Trial That Suits You.
One of the important considerations is will your loved one be eligible.
ELIGIBILITY
Inclusion Criteria for Alzheimer Trials typically are:
- Early Alzheimer’s disease (AD): Gradual and progressive subjective decline in the participant’s cognition over at least the past 6 months, as reported by the participant and informant (study partner) and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 and memory box score greater than or equal to (>=) 0.5
- Participants must have positive tau PET results
- Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
- Have a designated study partner who has adequate literacy to participate and be judged to have high likelihood of completing the study with the participant
- Male participants must agree not to donate sperm during the study and up to 16 weeks after the last dose of study intervention Exclusion Criteria:
- Participants with CDR GS >=1 during screening or at predose baseline CDR administration
- Participants who fulfill diagnostic criteria for Mild Cognitive Impairment (MCI) or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (eg, MCI/dementia due to frontotemporal lobar degeneration, diffuse lewy body disease, parkinson’s disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, (Et cetera[etc])
- Geriatric Depression Scale (GDS) 30 score >=11
- Rosen Modified Hachinski Ischemic Scale (HIS) > 4
- Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 2 months; that is, doses of chronic medications that effect the CNS should be stable for at least 2 months before the start of screening
After consideration of several such criteria, the study doctors will determine if the subject can be randomized to get the medication.