GV1001 for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GemVax & Kael

Prior Safety Data

Trial Summary

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

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.

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).

Treatment Details

Interventions

• GV1001 (Cancer Vaccine)

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

Group I: GV1001 1.12 mg Experimental Treatment 1 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 mg Experimental Treatment 1 Intervention

GV1001 0.56 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 50

Group III: Placebo Placebo Group 1 Intervention

Placebo SC injection administered once weekly for 4 weeks then every 2 weeks through Week 50

Who Is Running the Clinical Trial?

GemVax & Kael

Lead Sponsor

Trials

9

Recruited

1,800+