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CompletedPhase 2

SMART: Somatotrophics, Memory, and Aging Research Trial

GHRH: Cognition in Aging and MCI

Lead sponsor

University of Washington

Asset

TH9507 human growth hormone releasing hormone (GHRH)

Listed sites

Recruiting sites

Enrollment

151

actual

Study population

MCI / preclinical Alzheimer’s

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Declarative memory

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID28287-K

NCT IDNCT00257712

NihR01AG025515

NihR01AG025525-01A1

Timeline

Milestones

Study first posted2005-11-23estimated

Study start2006-02 (month precision)

Primary completion2011-12actual (month precision)

Study completion2011-12actual (month precision)

Last update posted2013-12-19estimated

Assets

Drug assets

TH9507 human growth hormone releasing hormone (GHRH)

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Memory

Global cognition

1 endpoint

Secondary/protocol endpoint

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

descriptive

Memory

1 endpoint

Primary/protocol endpoint

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

change from baseline, improvement

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.