Clinical experiment designed to assess clinical efficacy targeting APOE in recently menopausal women with good cardiovascular health. Primary outcome: Amyloid beta burden on PET, hippocampal atrophy, and dorsolateral prefrontal cortex thickness on MRI
This is a follow-up study to the Kronos Early Estrogen Prevention Study (KEEPS) that investigated the long-term effects of short-term menopausal hormone therapy on Alzheimer's disease biomarkers. The original KEEPS trial randomized recently menopausal women with good cardiovascular health to receive either oral conjugated equine estrogens (oCEE), transdermal 17β-estradiol (tE2) with micronized progesterone, or placebo for 4 years. Ten years after completion of the original trial, participants were reassessed using amyloid beta PET imaging, structural MRI to measure hippocampal atrophy and dorsolateral prefrontal cortex thickness. The study aimed to determine whether previous exposure to hormone therapy had any lasting effects on brain health and AD pathophysiology. The researchers also examined whether apolipoprotein E ε4 carrier status modified any observed effects. This represents one of the first long-term follow-up studies of a hormone therapy clinical trial using advanced neuroimaging biomarkers for Alzheimer's disease.
Participants from the original KEEPS trial were recontacted 10 years after completion. Amyloid beta burden was assessed using positron emission tomography. Structural MRI was performed to measure hippocampal atrophy and dorsolateral prefrontal cortex thickness. APOE ε4 genotyping was performed to assess genetic modifying effects.
The study hypothesized that imaging biomarkers would reveal early detection of evolving brain pathology if hormone therapy had long-term effects on AD risk
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