Mild Cognitive ImpairmentPhase 1NCT02553603
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
A Phase 1 study testing Growth Hormone Releasing Hormone (GHRH) in people with Mild Cognitive Impairment, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Growth Hormone Releasing Hormone (GHRH)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2017to 17 Jan 2019
- Phase
- Phase 1
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 55 to ≤ 85 years
- Ability to sign consent form (score ≥ on the Mini Mental State Examination, MMSE)
- MCI group: MMSE scores of 23 - 26
- Normal Control Group: MMSE scores of 27 - 30
Who cannot join
- Diabetes
- A neurologic condition other than MCI which might cause cognitive impairment
- Baseline serum IGF-1 concentration greater than the midrange for healthy young adults (300ng/ml)
- Presence of a pacemaker or metal implant
- Heart Failure
- Edema
Show all 19Show fewer
- Active malignancy
- Carpal tunnel syndrome
- Disruption of the hypothalamic pituitary axis such that the pituitary is expected to be insensitive to growth hormone secretagogues such as GHRH
- Known allergy to tesamorelin or mannitol
- Pregnancy
- Significant heart, liver, kidney, blood or respiratory disease
- Active cancer
- Recent (within 6 months) treatment with anabolic steroids, GHRH or corticosteroids
- Alcohol or drug abuse
- MMSE < 23
- Less than 12 years of education
- Significant findings on screening tests, including but not limited to, blood counts, blood biochemistries, urinalysis, drug screening, HIV test, hepatitis panel, electrocardiogram
- Other medical conditions deemed exclusionary by the study investigators
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77555
About this study
This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls.
Read the detailed description
Subjects with MCI as well as healthy controls will be given GHRH at a dose of 1mg/day for 10 weeks.
This study is designed to investigate the effects of GHRH on the following things: 1) cognitive function as measured by our neuropsychologist with a series of short tests; 2) brain activity as measured by fMRI 3) lean and fat mass of your body as measured by DEXA; 4) physical function as measured by a walking test.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Growth Hormone Releasing Hormone (GHRH), Placebo Growth Hormone Releasing Hormone
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Hormone Releasing Hormone (GHRH)Drug
Also called Egrifta, tesamorelin
Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
Placebo Growth Hormone Releasing HormoneDrug
Also called Placebo
Placebo GHRH to be given once daily for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mild Cognitive Impairment, Placebo | Placebo comparator | Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH). Receives: Drug: Placebo Growth Hormone Releasing Hormone |
| Non-cognitively impaired, Placebo | Placebo comparator | Subjects aged 55- 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH). Receives: Drug: Placebo Growth Hormone Releasing Hormone |
| Mild Cognitive Impairment, GHRH | Experimental | Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH). Receives: Drug: Growth Hormone Releasing Hormone (GHRH) |
| Non-cognitively impaired, GHRH | Experimental | Subjects aged 55 - 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH). Receives: Drug: Growth Hormone Releasing Hormone (GHRH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function measured by SLUMS
Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)
Measured: 10 weeks
Brain Perfusion measured by fMRI
Brain Perfusion at 10 week measured by MRI
Measured: 10 weeks
Brain Morphology measured by MRI
Brain Morphology at 10 weeks measured by MRI
Measured: 10 weeks
Secondary outcomes (2)
Body composition measured by DEXA
Body composition at 10 weeks measured by DEXA
Measured: 10 weeks
Physical Function measured by 6 minute walking test
Physical Function at 10 weeks measured by 6 minute walking test
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start18 Jul 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall J Urban, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553603
- Sponsor's protocol ID
- 15-0086
- Status last verified
- Oct 2019
- First submitted
- 3 Sep 2015
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Stewart CE, French KP, Wright TJ, Wilhoit K, Randolph KM, Danesi CP, Gilkison CR, Karmonik C, Lu L, Dillon EL, Durham WJ, Urban RJ, Sheffield-Moore M, Masel BE. The effect of growth hormone-releasing hormone on cognition and brain connectivity in adults with cognition ranging from normal to mild cognitive impairment. eNeurologicalSci. 2026 Jun 17;44:100616. doi: 10.1016/j.ensci.2026.100616. eCollection 2026 Sep.
PubMed 42382101
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02553603
- Acronym / sponsor ID
- 15-0086
- Conditions
- Mild Cognitive Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls.
Detailed description
Subjects with MCI as well as healthy controls will be given GHRH at a dose of 1mg/day for 10 weeks.
This study is designed to investigate the effects of GHRH on the following things: 1) cognitive function as measured by our neuropsychologist with a series of short tests; 2) brain activity as measured by fMRI 3) lean and fat mass of your body as measured by DEXA; 4) physical function as measured by a walking test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Cognitive Impairment, Placebo | Placebo comparator | Drug: Placebo Growth Hormone Releasing HormoneSubjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH). |
| Non-cognitively impaired, Placebo | Placebo comparator | Drug: Placebo Growth Hormone Releasing HormoneSubjects aged 55- 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH). |
| Mild Cognitive Impairment, GHRH | Experimental | Drug: Growth Hormone Releasing Hormone (GHRH)Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH). |
| Non-cognitively impaired, GHRH | Experimental | Drug: Growth Hormone Releasing Hormone (GHRH)Subjects aged 55 - 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH). |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 55 to ≤ 85 years
- Ability to sign consent form (score ≥ on the Mini Mental State Examination, MMSE)
- MCI group: MMSE scores of 23 - 26
- Normal Control Group: MMSE scores of 27 - 30
Key exclusion criteria (19 listed)
- Diabetes
- A neurologic condition other than MCI which might cause cognitive impairment
- Baseline serum IGF-1 concentration greater than the midrange for healthy young adults (300ng/ml)
- Presence of a pacemaker or metal implant
- Heart Failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth Hormone Releasing Hormone (GHRH)Also: Egrifta, tesamorelinGrowth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks | Drug | Mild Cognitive Impairment, GHRH, Non-cognitively impaired, GHRH |
| Placebo Growth Hormone Releasing HormoneAlso: PlaceboPlacebo GHRH to be given once daily for 10 weeks | Drug | Mild Cognitive Impairment, Placebo, Non-cognitively impaired, Placebo |
Primary outcome
Cognitive Function measured by SLUMS
Time frame: 10 weeks
Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)
Brain Perfusion measured by fMRI
Time frame: 10 weeks
Brain Perfusion at 10 week measured by MRI
Brain Morphology measured by MRI
Time frame: 10 weeks
Brain Morphology at 10 weeks measured by MRI
2 secondary outcomes
Body composition measured by DEXA
Time frame: 10 weeks
Physical Function measured by 6 minute walking test
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Derived from this study: PubMed 42382101Stewart CE, French KP, Wright TJ, Wilhoit K, Randolph KM, Danesi CP, Gilkison CR, Karmonik C, Lu L, Dillon EL, Durham WJ, Urban RJ, Sheffield-Moore M, Masel BE. The effect of growth hormone-releasing hormone on cognition and brain connectivity in adults with cognition ranging from normal to mild cognitive impairment. eNeurologicalSci. 2026 Jun 17;44:100616. doi: 10.1016/j.ensci.2026.100616. eCollection 2026 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall J Urban, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Growth Hormone Releasing Hormone (GHRH) in people with Mild Cognitive Impairment, run by The University of Texas Medical Branch, Galveston 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 4 inclusion and 19 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 4 Nov 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Cognitive Function measured by SLUMS (time frame: 10 weeks). The study lists 3 primary outcomes in all. 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 NCT02553603, which also lists 1 linked publication.
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 4 Nov 2019.