GV1001 for Alzheimer's Disease

No longer recruiting at 37 trial locations

Overseen By Jeongsun Park

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GemVax & Kael

Must be taking: AD medications

Must not be taking: Tricyclics, MAO inhibitors

Disqualifiers: Other dementia, Schizophrenia, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called GV1001 for individuals with mild to moderate Alzheimer's disease. Researchers believe the treatment protects brain cells and improves memory by reducing harmful proteins linked to Alzheimer's. Participants will receive either a low or high dose of GV1001 or a placebo (a substance with no active ingredients) through injections over about a year. Ideal candidates have a confirmed Alzheimer's diagnosis, experience memory problems, and are on a stable dose of any existing Alzheimer's medications. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that GV1001 is likely to be safe for humans?

Research has shown that GV1001 is well-tolerated by patients with Alzheimer's disease. In a study involving individuals with moderate to severe Alzheimer's, GV1001 produced positive effects without major safety issues. Participants did not experience significant side effects, suggesting the treatment is generally safe.

Earlier studies indicate that GV1001 helps protect brain cells from stress and damage caused by amyloid beta, a protein linked to Alzheimer's. This supports the idea that GV1001 could be a safe treatment option for Alzheimer's.

While the safety data for GV1001 is promising, joining a clinical trial can help build more evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Researchers are excited about GV1001 for Alzheimer's disease because it offers a novel approach compared to current treatments like donepezil, rivastigmine, and memantine, which primarily focus on managing symptoms. GV1001 is unique as it is derived from a peptide originally developed for cancer treatment, suggesting a different mechanism of action that might target the disease more directly. This treatment is also administered via a subcutaneous injection, which could offer more consistent drug delivery and potentially improve patient compliance. By potentially addressing Alzheimer's in a new way, GV1001 provides hope for more effective management of the condition.

What evidence suggests that GV1001 might be an effective treatment for Alzheimer's disease?

Research has shown that GV1001 may help treat Alzheimer's disease. In a completed study, patients with moderate to severe Alzheimer's who received GV1001, particularly at a dose of 1.12 mg, experienced significant improvements in cognitive abilities. The treatment noticeably reduced symptom severity compared to those who received a placebo. GV1001 lowers levels of harmful proteins, such as amyloid beta and tau, which are linked to Alzheimer's. Animal studies have also demonstrated improvements in memory and thinking. Overall, GV1001 appears to be a promising option for managing Alzheimer's symptoms. ^{1 3 4 5 6}

Who Is on the Research Team?

Jeongmi Kim

Principal Investigator

GemVax & KAEL Co., Ltd.

Are You a Good Fit for This Trial?

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).

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7995588/

Efficacy and safety of GV1001 in patients with moderate-to ... This clinical trial showed that GV1001, especially at a dose of 1.12 mg, effectively reduced the change in SIB scores compared with the placebo ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05303701

GV1001 Subcutaneous for the Treatment of Moderate to ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0889159123003203

GV1001 modulates neuroinflammation and improves ... We found that GV1001 improved memory and cognition in middle- and old-aged 3xTg-AD mice. Additionally, it reduced Aβ oligomer and phospho-tau (Ser202 and Thr205) ...

4. theaftd.org theaftd.org/posts/1ftd-in-the-news/blog-gemvax-kael-psp-drug/

GemVax & KAEL Announces Results from Phase 2a ... Prior research on GemVax's drug, GV1001, found it reduced disease-associated forms of tau in mouse models of Alzheimer's disease. In the ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33771205/

Efficacy and safety of GV1001 in patients with moderate-to- ... The results indicate that GV1001 1.12 mg met the primary endpoint of a statistically significant difference. GV1001 was well tolerated without safety concerns.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05189210

GV1001 Subcutaneous(SC) for the Treatment of Mild to ... 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 ...