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Trial · Interventional

CompletedPhase 2Registry data

SMART: Somatotrophics, Memory, and Aging Research Trial

NCTNCT00257712 (opens ClinicalTrials.gov in a new tab)Other id28287-KOther idR01AG025515Other idR01AG025525-01A1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
151 participants (actual)
Sponsor
University of Washington · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Feb 2006
Primary completion
Dec 2011
Completion
Dec 2011
First posted
23 Nov 2005 (estimated)
Last update posted
19 Dec 2013 (estimated)
Conditions
Aging · Mild Cognitive Impairment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009201020112012
  1. Ph 2

    SMART: Somatotrophics, Memory, and Aging Research Trial

    NCT00257712

    Feb 2006 to Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • TH9507 human growth hormone releasing hormone (GHRH)Drug

Arms2

  • Experimental

    1

  • Placebo comparator

    2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

Secondary outcomes(1)

  1. Changes in other areas of cognitive function, including other tests of executive function, tests of lexical access, and tests of cognitive and perceptual-motor processing speed.

    Time frame · Baseline, 10, 20, and 30 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2013

9 results

Growth hormone-releasing hormone effects on brain γ-aminobutyric acid levels in mild cognitive impairment and healthy aging.

Friedman et al. 2013JAMA neurologycited by 47

PMID 23689947PMC3764915DOI 10.1001/jamaneurol.2013.1425PUB-23689947

Rights unknown9 results
Source linkSee results (9)

Indexing hint: Randomized controlled trial · 2012

9 results

Effects of growth hormone–releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial.

Baker et al. 2012Archives of neurologycited by 106

PMID 22869065PMC3764914DOI 10.1001/archneurol.2012.1970PUB-22869065

Rights unknown9 results
Source linkSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 55 Years up to 90 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * Living at home with a reliable spouse, significant other or caregiver * Normal PSA (for men) or mammogram (for women) within one year of study entry The following inclusion criteria will be applied to identify potential MCI participants: * Memory complaint that can be corroborated by a study partner * Memory test scores meeting the diagnostic criteria for MCI * MMSE score greater than 20 The following inclusion criteria will be applied to identify potential normal control participants: * Cognitive testing does not indicate MCI * MMSE score greater than 28 Exclusion Criteria: * Use of medications known to affect the GHRH/GH/IGF-I axis, including transdermal estrogens (use of oral estrogens is not contraindicated) * Significant medical illness or organ failure, such as uncontrolled hypertension, diabetes, cardiac disease, cerebrovascular disease, chronic obstructive pulmonary disease, kidney and liver disease * Significant neurologic disease that might affect cognition, such as Alzheimer's disease, stroke, Parkinson's disease, multiple sclerosis, severe head injury with loss of consciousness for more than 30 minutes or with permanent neurologic sequelae * Personal or strong family history of cancer (especially colon, breast or melanoma) * Evidence for pituitary disease by history or physical examination * Symptoms or history of carpal tunnel or a positive Phalen's Test * Active arthritis * Significant current psychiatric illness, such as depression, schizophrenia or an Axis II diagnosis suggestive of an inability to successfully complete the study protocol * Current use of an anti-psychotic, anti-depressant, anti-convulsant, anti-coagulant, anxiolytic or sedative * Current or planned use of DHEA, testosterone or cognition-enhancing medication (e.g., cholinesterase inhibitors, memantine) * Weight greater than 150% ideal body weight * Tobacco use, excessive alcohol intake (more than 2 drinks per day), excessive caffeine intake (more than 4 cups of coffee per day) * Baseline IGF-I level greater than the mid-range for healthy young adults (250 ng/ml) * Meets NINCDS/ADRDA criteria for AD

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