Trial · NCT05819658

GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)

NCT05819658, Phase 2, Completed, GemVax & Kael; results first posted 2026-02-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP). Trials, record NCT05819658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05819658

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)
NCT number: NCT05819658
Status: Completed
Phases: Phase 2
Enrollment: 78 participants, actual
Lead sponsor: GemVax & Kael
Conditions: Progressive Supranuclear Palsy
Interventions: GV1001 Placebo, GV1001 0.56mg, GV1001 1.12mg
First posted: 2023-04-19
Last updated: 2026-02-10
Results first posted: 2026-02-10

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From the Baseline in the Total Score of PSP-rating Scale	24 weeks(6 months)	Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.
Secondary	Change From the Baseline in the Total Score of PSP-rating Scale	12 Weeks(3 months)	Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.
Secondary	Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)	12 weeks (3 Months)	Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.
Secondary	Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)	24 weeks(6 months)	Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.
Secondary	Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)	12 weeks(3 months)	Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.
Secondary	Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)	24 weeks(6 months)	Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.
Secondary	Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale	12 weeks(3 months)	Change from the baseline in the England \& Schwab Activity of Daily Living (ES ADL) scale after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.
Secondary	Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale	24 weeks(6 months)	Change from the baseline in the England \& Schwab Activity of Daily Living (ES ADL) scale after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.
Secondary	Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)	12 weeks(3 months)	Change from the baseline in the score of \[History\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 24 with a higher score indicating severely impaired cognitive function.
Secondary	Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)	24 weeks(6 months)	Change from the baseline in the score of \[History\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 24 with a higher score indicating severely impaired cognitive function.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From the Baseline in the Total Score of PSP-rating Scale	24 weeks(6 months)	Participants who completed 24 weeks (6 months) were included.	scores on a scale	MEAN
SECONDARY	Change From the Baseline in the Total Score of PSP-rating Scale	12 Weeks(3 months)	Participants who completed 12 weeks (3 months) were included.	scores on a scale	MEAN
SECONDARY	Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)	12 weeks (3 Months)	Participants who completed 12 weeks (3 months) were included.	scores on a scale	MEAN
SECONDARY	Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)	24 weeks(6 months)	Participants who completed 24 weeks (6 months) were included.	scores on a scale	MEAN
SECONDARY	Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)	12 weeks(3 months)	Participants who completed 12 weeks (3 months) were included.	scores on a scale	MEAN
SECONDARY	Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)	24 weeks(6 months)	Participants who completed 24 weeks (6 months) were included.	scores on a scale	MEAN
SECONDARY	Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale	12 weeks(3 months)	Participants who completed 12 weeks (3 months) were included.	scores on a scale	MEAN
SECONDARY	Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale	24 weeks(6 months)	Participants who completed 24 weeks (6 months) were included.	scores on a scale	MEAN
SECONDARY	Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)	12 weeks(3 months)	Participants who completed 12 weeks (3 months) were included.	scores on a scale	MEAN
SECONDARY	Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)	24 weeks(6 months)	Participants who completed 24 weeks (6 months) were included.	scores on a scale	MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group66

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From the Baseline in the Total Score of PSP-rating Scale	Placebo	4.10	Standard Deviation 1.69	scores on a scale
Change From the Baseline in the Total Score of PSP-rating Scale	GV1001 0.56 mg	2.14	Standard Deviation 1.78	scores on a scale
Change From the Baseline in the Total Score of PSP-rating Scale	GV1001 1.12 mg	6.46	Standard Deviation 1.64	scores on a scale
Change From the Baseline in the Total Score of PSP-rating Scale	Placebo	1.42	Standard Deviation 1.60	scores on a scale
Change From the Baseline in the Total Score of PSP-rating Scale	GV1001 0.56 mg	-0.47	Standard Deviation 1.65	scores on a scale
Change From the Baseline in the Total Score of PSP-rating Scale	GV1001 1.12 mg	2.75	Standard Deviation 1.55	scores on a scale
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)	Placebo	0.25	Standard Deviation 0.61	scores on a scale
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)	GV1001 0.56 mg	0.93	Standard Deviation 0.64	scores on a scale
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)	GV1001 1.12 mg	0.26	Standard Deviation 0.60	scores on a scale
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)	Placebo	0.29	Standard Deviation 0.73	scores on a scale

1 to 10 of 66Source ClinicalTrials.gov

See all 66 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	25
Overall Study	STARTED	GV1001 0.56 mg	25
Overall Study	STARTED	GV1001 1.12 mg	28
Overall Study	COMPLETED	Placebo	22
Overall Study	COMPLETED	GV1001 0.56 mg	20
Overall Study	COMPLETED	GV1001 1.12 mg	25
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	GV1001 0.56 mg	5
Overall Study	NOT COMPLETED	GV1001 1.12 mg	3

Source ClinicalTrials.gov

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Skin laceration	Injury, poisoning and procedural complications	Placebo	2	24	2
other	Skin laceration	Injury, poisoning and procedural complications	GV1001 0.56 mg	2	24	2
other	Skin laceration	Injury, poisoning and procedural complications	GV1001 1.12 mg	0	28	0
other	Skin abrasion	Injury, poisoning and procedural complications	Placebo	2	24	2
other	Skin abrasion	Injury, poisoning and procedural complications	GV1001 0.56 mg	0	24	0
other	Skin abrasion	Injury, poisoning and procedural complications	GV1001 1.12 mg	0	28	0
other	Injection site erythema	General disorders	Placebo	2	24	11
other	Injection site erythema	General disorders	GV1001 0.56 mg	1	24	4
other	Injection site erythema	General disorders	GV1001 1.12 mg	3	28	9
other	Chest pain	General disorders	Placebo	3	24	3

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	24
Total, all-cause mortality	GV1001 0.56 mg	0	24
Total, all-cause mortality	GV1001 1.12 mg	0	28
Total, other adverse events	Placebo	15	24
Total, other adverse events	GV1001 0.56 mg	12	24
Total, other adverse events	GV1001 1.12 mg	9	28
Total, serious adverse events	Placebo	3	24
Total, serious adverse events	GV1001 0.56 mg	2	24
Total, serious adverse events	GV1001 1.12 mg	5	28

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05819658

GET https://conductscience.org/api/trials/v1/NCT05819658/registered?page=2

API reference For AI assistants