Clinical studies have provided contradictory findings about the cognitive and mood effects of menopausal hormone therapies and underscored the need for additional research and longer-term effects.

The Kronos Early Estrogen Prevention Study (KEEPS) Continuation study assesses the effects of menopausal hormone therapy and normal aging on cognitive performance and imaging markers of Alzheimer's disease and brain structure in women who participated in the original KEEPS trial, 13 years after they enrolled in the initial KEEPS trial.

Study protocol

In the initial KEEPS study, participants were randomized to a pill or a patch form of estrogen treatments or matching placebo within three years of menopause. This is a follow-up study of these women 13 years after enrollment (nine years after study completion).

No treatments are given as part of the KEEPS Continuation study. All participants complete the following:

  • Medical history collection and review
  • Physical examination
  • MRI scan
  • PET-CT scan
  • Blood tests
  • Cognitive testing
  • Study questionnaires

The aim of the continuation study is to determine differences in cognitive function and imaging markers of cognitive health on MRI and PET scans in women who were using oral or transdermal estrogen treatments compared with women in the placebo group.

Download the KEEPS Continuation study brochure (PDF).

Inclusion criteria

To be eligible for the KEEPS Continuation study, participants must meet the following criteria:

  • Have been enrolled in the initial KEEPS trial
  • Be able to understand study procedures
  • Be willing to sign an authorization of consent to participate

Exclusion criteria

Participants who meet all the inclusion criteria but have contraindications to an MRI for safety reasons, such as an MRI-incompatible implant, are not eligible to participate in MRI and PET studies. They are still eligible to participate in the remainder of the study.