What is the mechanism of action of this treatment?

Common treatments for Alzheimer's Disease (AD) include aducanumab, which targets amyloid-beta plaques to reduce their accumulation in the brain, potentially slowing disease progression. Antioxidants like vitamin E aim to mitigate oxidative stress, which is believed to contribute to neuronal damage in AD. Hormone replacement therapy (HRT) has been explored for its potential cognitive benefits, although results are inconsistent. Understanding these mechanisms is crucial as they address different pathological aspects of AD, providing a comprehensive approach to managing the disease.

What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and NMDA receptor antagonists (memantine), have known side effects. Cholinesterase inhibitors often cause gastrointestinal issues like nausea, vomiting, and diarrhea, along with muscle cramps, fatigue, and insomnia. Memantine can lead to dizziness, headache, confusion, and constipation. Newer treatments like aducanumab, which targets amyloid plaques, have been associated with brain swelling and microhemorrhages. This summary provides an overview of the side effects of the most common AD treatments.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on symptom management and slowing disease progression. Notable approvals include aducanumab, a monoclonal antibody that targets amyloid-beta plaques, which was approved despite mixed clinical trial results. Other treatments include cholinesterase inhibitors like donepezil and galantamine, which enhance cholinergic function, and memantine, an NMDA receptor antagonist that helps regulate glutamate activity. These drugs aim to improve cognitive function and delay the progression of symptoms in Alzheimer's patients.

What other types of research exist?

Promising alternatives to AR1001 for Alzheimer's Disease treatment in 2024 include: 1) Anti-Aβ drugs such as aducanumab and lecanemab, which target amyloid plaques. 2) Tau-targeting therapies like semorinemab and tilavonemab. 3) Innovative approaches such as antisense oligonucleotides and CRISPR-Cas9 gene editing targeting genetic mutations associated with AD. 4) Plasmonic nanoparticle-based drug-screening methods for more effective drug development.

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Unknown

AR1001 for Alzheimer's Disease

Verified Trial

Phase 3

Recruiting

Research Sponsored by AriBio Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female participants aged 55 to 90 years of age inclusive at the time of signing the informed consent form

Mild cognitive impairment or mild dementia consistent with AD defined by stages 3 to 4 according to the National Institute on Aging and Alzheimer's Association (NIA-AA) at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 156 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests AR1001, a medicine for early Alzheimer's Disease. It focuses on people in the early stages of Alzheimer's, aiming to improve their condition through multiple mechanisms.

Who is the study for?

Adults aged 55-90 with early Alzheimer's Disease (AD), confirmed by specific cognitive tests and biomarkers, can join this trial. They need a reliable caregiver to assist and must not have other dementia causes or severe health issues like recent heart problems, uncontrolled seizures, or certain infections.

What is being tested?

The study is testing AR1001 against a placebo in people with early AD. It's a Phase 3 trial where participants are randomly assigned to either the new drug or an inactive substance without knowing which one they receive.

What are the potential side effects?

While the side effects of AR1001 aren't specified here, similar drugs may cause gastrointestinal issues, confusion, dizziness, headaches, and allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 55 and 90 years old.

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I have mild memory loss or mild dementia due to Alzheimer's disease.

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You have experienced memory and thinking problems in the last 5 years, confirmed by a study partner.

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My MRI ruled out other causes for my dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 156 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~156 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 156 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

Secondary study objectives

Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-Cog 13)

Amsterdam-Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV)

Geriatric Depression Scale (GDS)

+1 more

Other study objectives

Biomarker Analysis

Exploratory Analysis

Safety Analysis

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Group A - Active ComparatorActive Control1 Intervention

Active, AR1001 30 mg QD will be administered daily for 52 weeks during the Treatment Phase of the study. In the Extension Phase, all eligible participants who choose to participate will receive AR1001 30 mg QD for 104 weeks.

Group II: Group B - Placebo ComparatorPlacebo Group1 Intervention

Placebo QD will be administered daily for 52 weeks during the Treatment Phase of the study. In the Extension Phase, all eligible participants who choose to participate will receive AR1001 30 mg QD for 104 weeks.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) include aducanumab, which targets amyloid-beta plaques to reduce their accumulation in the brain, potentially slowing disease progression. Antioxidants like vitamin E aim to mitigate oxidative stress, which is believed to contribute to neuronal damage in AD. Hormone replacement therapy (HRT) has been explored for its potential cognitive benefits, although results are inconsistent. Understanding these mechanisms is crucial as they address different pathological aspects of AD, providing a comprehensive approach to managing the disease.