Aging Clinical Trial
Official title:
GHRH: Cognition in Aging and MCI
The purpose of the SMART study was to better understand whether the body's own production of growth hormone (GH) would improve memory and problem solving ability, or cognitive function. 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).
There is considerable and compelling evidence from both the animal and human literature that
the actions of the somatotrophic hormonal axis (growth hormone releasing hormone/growth
hormone/insulin-like growth factor I) have significant and predictable effects on cognitive
function (memory and reasoning ability). A preliminary study has recently shown that five
months of growth hormone releasing hormone (GHRH) treatment improves cognitive function in
healthy older men and women; there is also preliminary evidence that supports the likelihood
of a similar effect in individuals diagnosed with MCI.
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). ERT women will maintain a regular steady dosage of estrogens for
at least seven days preceding each assessment
Cognitive assessments to evaluate treatment-related changes in memory and thinking abilities,
as well as blood collection to evaluate several biomarkers of interest, will be performed at
baseline, 10 and 20 weeks of treatment, and ten weeks post-treatment. In addition there will
be five medication and symptom monitoring visits during the treatment period.
The study hypotheses are:
H1: Healthy, cognitively normal older men and women treated with GHRH will show beneficial
effects in cognitive function, including measures of memory, relative to placebo treated
subjects.
H2: MCI patients treated with GHRH will show beneficial effects in cognitive function,
including measures of memory, relative to placebo treated MCI patients.
H3: Changes in insulin-like-growth factor (IGF-I) will predict changes in cognition both for
normal older adults and for MCI patients treated with GHRH.
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