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Neuroprotective Effects of ACTH4-10PRO8-GLY9-PRO10

Primary Purpose

Ketamine-Induced Neurotoxicity

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
ACTH4-10Pro8-Gly9-Pro10
Ketamine
Sponsored by
Universitas Sumatera Utara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ketamine-Induced Neurotoxicity focused on measuring ACTH4-10Pro8-Gly9-Pro10, BDNF, ketamine-induced neurotoxicity, apoptosis

Eligibility Criteria

7 Days - 7 Days (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria: Rattus norvegicus rats Male, seven days old, weighing 15-20 grams Spraque-Dawley strain, obtained from the Experimental Animal Care Unit Exclusion Criteria: Animals that behave aggressively in observation by attacking other groups

Sites / Locations

  • Faculty of Medicine Universitas Sumatera Utara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACTH4-10PRO8-GLY9-PRO10

ketamine 40 mg/kg BW subcutaneously

Arm Description

The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of a short fragment of adrenocorticotropic hormone (ACTH). It is free from hormonal effects and has neuromodulatory effects.

ketamine results in impaired brain function associated with neuroapoptosis injury in the immature brain.

Outcomes

Primary Outcome Measures

BDNF Expression
a protein that, in humans, is encoded by the BDNF gene
BDNF Serum Concentrations
a protein that, in humans, is encoded by the BDNF gene

Secondary Outcome Measures

Full Information

First Posted
December 5, 2022
Last Updated
December 5, 2022
Sponsor
Universitas Sumatera Utara
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1. Study Identification

Unique Protocol Identification Number
NCT05648526
Brief Title
Neuroprotective Effects of ACTH4-10PRO8-GLY9-PRO10
Official Title
Neuroprotective Effects of ACTH4-10PRO8-GLY9-PRO10 on The Ketamine-Induced Neurotoxicity In Neonatal Rats: Increased BDNF Expression And BDNF Serum Concentrations
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sumatera Utara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of an adrenocorticotropic hormone (ACTH) short fragment. That is free from hormonal effects and has neuromodulatory effects. We investigate the neuroprotective effects of ACTH4-10Pro8-Gly9-Pro10 can lessen neurotoxicity against ketamine in neonatal rats by looking at BDNF expression in the cortex and hippocampus tissue as well as BDNF blood levels.
Detailed Description
The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of a short fragment of adrenocorticotropic hormone (ACTH). It is free from hormonal effects and has neuromodulatory effects. The immune-modulating and neurotrophic activity of the drug were shown to balance the state of anti-inflammatory and trophic factors (IL-IO, TNF-a, TGF-Pl, BDNF, NGF) over proinflammatory factors (IL-Ip, IL-8, CRP, LE) to increase the anti-apoptotic defense (Bcl-2 elevation), as well as to reduce the peroxidation process (increased SOD activity). ACTH4-10Pro8-Gly9-Pro10 also has neuromodulator characteristics to function as a neuroprotector in inhibiting the apoptotic process. Modulation by ACTH4-10Pro8-Gly9-Pro10 will increase the levels of BDNF thereby inhibiting the process of apoptosis. Based on research by Gusev and Skvortsova, ischemic stroke patients who were given ACTH4-10Pro8-Gly9-Pro10 showed increased levels of BDNF, decreased mortality, and reduced length of stay. Based on the description above, the researcher was interested in analyzing the effect of the administration of ACTH4-10Pro8-Gly9-Pro10 on ketamine neurotoxicity in neonatal rats by assessing the level of BDNF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketamine-Induced Neurotoxicity
Keywords
ACTH4-10Pro8-Gly9-Pro10, BDNF, ketamine-induced neurotoxicity, apoptosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACTH4-10PRO8-GLY9-PRO10
Arm Type
Experimental
Arm Description
The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of a short fragment of adrenocorticotropic hormone (ACTH). It is free from hormonal effects and has neuromodulatory effects.
Arm Title
ketamine 40 mg/kg BW subcutaneously
Arm Type
Active Comparator
Arm Description
ketamine results in impaired brain function associated with neuroapoptosis injury in the immature brain.
Intervention Type
Drug
Intervention Name(s)
ACTH4-10Pro8-Gly9-Pro10
Intervention Description
ACTH4-10Pro8-Gly9-Pro10 also has neuromodulator characteristics to function as a neuroprotector in inhibiting the apoptotic process. Modulation by ACTH4-10Pro8-Gly9-Pro10 will increase the levels of BDNF thereby inhibiting the process of apoptosis
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
negative-positive control (ketamine 40 mg/kg BW subcutaneously)
Primary Outcome Measure Information:
Title
BDNF Expression
Description
a protein that, in humans, is encoded by the BDNF gene
Time Frame
On 6 hours after the study drug dose
Title
BDNF Serum Concentrations
Description
a protein that, in humans, is encoded by the BDNF gene
Time Frame
On 6 hours after the study drug dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rattus norvegicus rats Male, seven days old, weighing 15-20 grams Spraque-Dawley strain, obtained from the Experimental Animal Care Unit Exclusion Criteria: Animals that behave aggressively in observation by attacking other groups
Facility Information:
Facility Name
Faculty of Medicine Universitas Sumatera Utara
City
Medan
State/Province
Sumatera Utara
ZIP/Postal Code
20155
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22908104
Citation
Ing C, DiMaggio C, Whitehouse A, Hegarty MK, Brady J, von Ungern-Sternberg BS, Davidson A, Wood AJ, Li G, Sun LS. Long-term differences in language and cognitive function after childhood exposure to anesthesia. Pediatrics. 2012 Sep;130(3):e476-85. doi: 10.1542/peds.2011-3822. Epub 2012 Aug 20.
Results Reference
background
PubMed Identifier
21969289
Citation
Flick RP, Katusic SK, Colligan RC, Wilder RT, Voigt RG, Olson MD, Sprung J, Weaver AL, Schroeder DR, Warner DO. Cognitive and behavioral outcomes after early exposure to anesthesia and surgery. Pediatrics. 2011 Nov;128(5):e1053-61. doi: 10.1542/peds.2011-0351. Epub 2011 Oct 3. Erratum In: Pediatrics. 2012 Mar;129(3):595.
Results Reference
result

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Neuroprotective Effects of ACTH4-10PRO8-GLY9-PRO10

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