Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women

What Was Tested

This registered not phased trial tested Leuprolide.

Complaints about memory and thinking are common in women as they go through menopause and estrogen levels fall.

Estrogen is also important for maintaining healthy blood vessels which also support normal cognitive function.

It had two arms (groups): Placebo (placebo comparator) and GnRH agonist (active comparator).

Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230).

The registry classes the interventions as drug.

Who Took Part

The registry lists 17 actual participants took part.

It was open to women only aged from 40 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Volunteers will be healthy women aged 40 to 60 years. Are enrolled in the parent FAME study (NCT01712230).

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: mini-mental state examination (mmse) score 27 or less; history of neurologic disease or major psychiatric illness; major depressive episode within the past 12 months.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Leuprolide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2014-09-08 with completion listed for 2017-05-30.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Changes in Prefrontal Cortex Brain Activation at 6 Months (time frame: Baseline, 6 months). Changes in Prefrontal Cortex Brain Activation at 9 Months (time frame: Baseline, 9 months).

It also tracked 16 secondary outcomes, for example Changes in Endothelial Function at 6 Months, Changes in Endothelial Function at 9 Months, Changes in Artery Compliance at 6 Months, Changes in Artery Compliance at 9 Months, Changes in Executive Cognitive Function: Trails A, 6 Months and Changes in Executive Cognitive Function: Trails A, 9 Months.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Leuprolide in 17 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.