NCT00257712

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

5.8 years

First QC Date

November 21, 2005

Last Update Submit

December 17, 2013

Conditions

AgingMild Cognitive Impairment

Keywords

Alzheimer's diseasecognition disorders

Outcome Measures

Primary Outcomes (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.

    Baseline, 10, 20, and 30 weeks

Secondary Outcomes (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.

    Baseline, 10, 20, and 30 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: TH9507 human growth hormone releasing hormone (GHRH)

2

PLACEBO COMPARATOR
Drug: TH9507 human growth hormone releasing hormone (GHRH)

Interventions

TH9507 human growth hormone releasing hormone (GHRH)DRUG

1mg subcutaneous injection given daily for 20 weeks

12

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give and understand informed consent
  • Able to communicate in English
  • 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
  • Memory complaint that can be corroborated by a study partner
  • Memory test scores meeting the diagnostic criteria for MCI
  • MMSE score greater than 20
  • Cognitive testing does not indicate MCI
  • MMSE score greater than 28

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (4)

  • Merriam GR, Schwartz RS, Vitiello MV. Growth hormone-releasing hormone and growth hormone secretagogues in normal aging. Endocrine. 2003 Oct;22(1):41-8. doi: 10.1385/ENDO:22:1:41.

    PMID: 14610297BACKGROUND

  • Vitiello MV, Moe KE, Merriam GR, Mazzoni G, Buchner DH, Schwartz RS. Growth hormone releasing hormone improves the cognition of healthy older adults. Neurobiol Aging. 2006 Feb;27(2):318-23. doi: 10.1016/j.neurobiolaging.2005.01.010. Epub 2005 Mar 23.

    PMID: 16399214BACKGROUND

  • Friedman SD, Baker LD, Borson S, Jensen JE, Barsness SM, Craft S, Merriam GR, Otto RK, Novotny EJ, Vitiello MV. Growth hormone-releasing hormone effects on brain gamma-aminobutyric acid levels in mild cognitive impairment and healthy aging. JAMA Neurol. 2013 Jul;70(7):883-90. doi: 10.1001/jamaneurol.2013.1425.

    PMID: 23689947DERIVED

  • Baker LD, Barsness SM, Borson S, Merriam GR, Friedman SD, Craft S, Vitiello MV. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Arch Neurol. 2012 Nov;69(11):1420-9. doi: 10.1001/archneurol.2012.1970.

    PMID: 22869065DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseCognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Michael V. Vitiello, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Suzanne Barsness, RN,MSN,CCRC

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Professor

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 23, 2005

Study Start

February 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 19, 2013

Record last verified: 2013-12

Locations

US(1)