180 Participants Needed

GV1001 for Alzheimer's Disease

Recruiting at 4 trial locations
MM
JP
Overseen ByJeongsun Park
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: GemVax & Kael
Must be taking: AD medications
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

If you are taking an approved medication for Alzheimer's disease, you must have been on a stable dose for at least 12 weeks before the study and continue it throughout the study. Some medications like tricyclic antidepressants and MAO inhibitors are not allowed, and the use of anxiolytics, narcotics, or sleep aids should not interfere with cognitive testing.

Is GV1001 safe for humans?

The safety of GV1001 has been demonstrated in patients with moderate-to-severe Alzheimer's disease, indicating it is generally safe for human use.12345

How does the drug GV1001 differ from other Alzheimer's treatments?

GV1001 is unique because it may target neuroinflammation and neuronal dysfunction by modulating proteins like S100B, which are involved in Alzheimer's disease progression. This approach is different from other treatments that primarily focus on reducing amyloid plaques.678910

What is the purpose of this trial?

The current study is being conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered subcutaneously as a treatment for mild to moderate Alzheimer's disease (AD). Studies using in vivo and in vitro AD models have shown that GV1001 inhibits neurotoxicity, apoptosis, and the production of reactive oxygen species induced by amyloid beta (Aβ) in neural stem cells by mimicking the extra-telomeric functions of human telomerase reverse transcriptase (hTERT). In nonclinical studies, using both mild (early stage) and severe (late stage) AD mouse models, GV1001 was shown to improve cognitive function and memory, as well as significantly reduce the amount of Aβ and tau proteins. The multifunctional effect of GV1001 makes it a promising therapeutic option for the treatment for AD. In a completed Phase 2 study conducted in Korea, GV1001 showed significant improvement in change from baseline of Severe Impairment Battery score at Week 24 and demonstrated a clinically acceptable safety profile in patients with moderate to severe AD.

Research Team

SK

Sangjae Kim

Principal Investigator

GemVax & KAEL Co., Ltd.

Eligibility Criteria

This trial is for individuals aged 55-85 with mild to moderate Alzheimer's, as shown by specific memory and cognition tests. They must have had a brain scan within the last two years consistent with Alzheimer's and no other dementia causes. Participants should be on stable Alzheimer's medication for at least three months and not part of another study recently.

Inclusion Criteria

I have been diagnosed with Alzheimer's disease by a specialist.
I am a male and will use effective birth control during and for 3 months after treatment.
You had a special brain scan or a spinal fluid test in the past 2 years that showed signs of a certain kind of brain problem.
See 8 more

Exclusion Criteria

I have not been diagnosed with any other cancer in the last 5 years.
Pregnancy, breast feeding, planning a pregnancy, or fathering a child while enrolled in the study or for 3 months after the last dose of study treatment
My kidney function is low (CrCL <30 mL/min).
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive GV1001 or placebo subcutaneously once weekly for 4 weeks, then every 2 weeks through Week 50

52 weeks
Weekly visits for 4 weeks, then bi-weekly visits through Week 50

End-of-Study (EOS)

Participants undergo final assessments 2 weeks after the last dose of study drug

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • GV1001
Trial Overview The trial is testing GV1001, given as an injection under the skin in two different doses (0.56mg and 1.12mg), against a placebo to see if it can treat mild to moderate Alzheimer’s disease by protecting nerve cells from damage caused by amyloid beta proteins.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: GV1001 1.12 mgExperimental Treatment1 Intervention
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 50
Group II: GV1001 0.56 mgExperimental Treatment1 Intervention
GV1001 0.56 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 50
Group III: PlaceboPlacebo Group1 Intervention
Placebo SC injection administered once weekly for 4 weeks then every 2 weeks through Week 50

Find a Clinic Near You

Who Is Running the Clinical Trial?

GemVax & Kael

Lead Sponsor

Trials
9
Recruited
1,800+

Findings from Research

A survey of two national pharmacovigilance databases revealed that rivastigmine, a cholinesterase inhibitor used for dementia, is associated with a significantly higher frequency of reported deaths compared to other similar medications, with reporting odds ratios indicating a strong correlation.
Despite the effectiveness of cholinesterase inhibitors in treating Alzheimer's disease, the increased risk of fatal outcomes with rivastigmine should be carefully considered when prescribing this medication.
Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada.Ali, TB., Schleret, TR., Reilly, BM., et al.[2022]
In a 6-month observational study involving 2,570 patients with Alzheimer's disease, memantine significantly improved cognitive function and daily living activities, as measured by the MMSE and IADL scales.
The treatment was well tolerated, with only 7.1% of patients reporting adverse drug reactions, and a very low discontinuation rate of 0.7% due to these reactions, indicating a favorable safety profile.
An open-label, multicenter observational study for patients with Alzheimer's disease treated with memantine in the clinical practice.Stamouli, SS., Tzanakaki, M., Giatas, S., et al.[2021]

References

Efficacy and safety of sodium oligomannate in the treatment of Alzheimer's disease. [2022]
Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada. [2022]
Alzheimer's disease and the glutamate NMDA receptor. [2013]
Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales. [2023]
An open-label, multicenter observational study for patients with Alzheimer's disease treated with memantine in the clinical practice. [2021]
Enhanced susceptibility of S-100B transgenic mice to neuroinflammation and neuronal dysfunction induced by intracerebroventricular infusion of human beta-amyloid. [2022]
S100 beta increases levels of beta-amyloid precursor protein and its encoding mRNA in rat neuronal cultures. [2019]
PSAPP mice exhibit regionally selective reductions in gliosis and plaque deposition in response to S100B ablation. [2021]
The Ca2+ sensor S100A1 modulates neuroinflammation, histopathology and Akt activity in the PSAPP Alzheimer's disease mouse model. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Increased S100 beta neurotrophic activity in Alzheimer's disease temporal lobe. [2019]
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