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AgingPhase 2NCT00257712

SMART: Somatotrophics, Memory, and Aging Research Trial

A Phase 2 study testing TH9507 human growth hormone releasing hormone (GHRH) in people with Aging and Mild Cognitive Impairment, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Mild Cognitive Impairment
What is being tested?
TH9507 human growth hormone releasing hormone (GHRH)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
151 participants
Where
1 siteUnited States
Study dates
Feb 2006to Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to 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
  • Living at home with a reliable spouse, significant other or caregiver
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

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).

Read the detailed description

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.

Being tested
TH9507 human growth hormone releasing hormone (GHRH)
Keywords
Alzheimer's disease, cognition disorders
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TH9507 human growth hormone releasing hormone (GHRH)Drug

    1mg subcutaneous injection given daily for 20 weeks

Study groups in NCT00257712
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: TH9507 human growth hormone releasing hormone (GHRH)
2Placebo comparatorNot described
Receives: Drug: TH9507 human growth hormone releasing hormone (GHRH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Baseline, 10, 20, and 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2005 (estimated)
  2. Study startFeb 2006
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00257712
Sponsor's protocol ID
28287-K
Other IDs
R01AG025515, R01AG025525-01A1
Status last verified
Dec 2013
First submitted
21 Nov 2005
Last updated
19 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14610297

  • 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.

    PubMed 16399214

  • 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.

    PubMed 23689947

  • 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.

    PubMed 22869065

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TH9507 human growth hormone releasing hormone (GHRH) in people with Aging and Mild Cognitive Impairment, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00257712, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.

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