SMART: Somatotrophics, Memory, and Aging Research Trial

What Was Tested

In this phase 2 trial, researchers set out to test Tesamorelin and GHRH (Growth Hormone-Releasing Hormone).

The study was a double blind, placebo-controlled study of the cognitive effects of growth hormone releasing hormone (GHRH) in healthy older men and women and in those with mild cognitive impairment (MCI).

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The study sample will include 160 adults, ages 55-90, half of whom will be cognitively healthy normal adults and half of whom will meet diagnostic criteria for Mild Cognitive Impairment (MCI).

Each of these groups will contain equal numbers of men and women.

The treatment with GHRH will be twenty weeks in duration.

In light of the documented interactions between estrogens and GHRH/GH/IGF-I, each of the two study arms will contain equal proportions of women not on estrogen replacement therapy (NERT) and women on oral estrogen replacement therapy (ERT).

Who Took Part

The registry lists 151 actual participants took part.

It was open to people of any sex aged from 55 years up to 90 years.

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

Examples of who could join: Able to give and understand informed consent. Able to communicate in English. No exclusionary criteria apply. Age between 55 and 90 years. Independent in their daily living abilities.

The full record lists 12 inclusion and 14 exclusion criteria; among the exclusions: use of medications known to affect the ghrh/gh/igf-i axis, including transdermal estrogens (use of oral estrogens is not contraindicated); personal or strong family history of cancer (especially colon, breast or melanoma); evidence for pituitary disease by history or physical examination.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

The Tesamorelin group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and investigator.

It started in 2006-02 with completion listed for 2011-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in declarative memory, including total recall scores on three tests of memory and on dual task response time (RT), a test of executive function (time frame: Baseline, 10, 20, and 30 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesamorelin and GHRH (Growth Hormone-Releasing Hormone) in 151 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tesamorelin compound page and the GHRH (Growth Hormone-Releasing Hormone) compound page, all human trials.