NCT02553603

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2017

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

September 3, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 18, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

September 3, 2015

Last Update Submit

November 1, 2019

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

  • Cognitive Function measured by SLUMS

    Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)

    10 weeks

  • Brain Perfusion measured by fMRI

    Brain Perfusion at 10 week measured by MRI

    10 weeks

  • Brain Morphology measured by MRI

    Brain Morphology at 10 weeks measured by MRI

    10 weeks

Secondary Outcomes (2)

  • Body composition measured by DEXA

    10 weeks

  • Physical Function measured by 6 minute walking test

    10 weeks

Study Arms (4)

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).

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).

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).

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).

Drug: Growth Hormone Releasing Hormone (GHRH)

Interventions

Growth Hormone Releasing Hormone (GHRH)DRUG

Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks

Also known as: Egrifta, tesamorelin
Mild Cognitive Impairment, GHRHNon-cognitively impaired, GHRH
Placebo Growth Hormone Releasing HormoneDRUG

Placebo GHRH to be given once daily for 10 weeks

Also known as: Placebo
Mild Cognitive Impairment, PlaceboNon-cognitively impaired, Placebo

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Growth Hormone-Releasing Hormonetesamorelin

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Randall J Urban, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 17, 2015

Study Start

July 18, 2017

Primary Completion

January 17, 2019

Study Completion

January 17, 2019

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

US(1)