What is the mechanism of action of this treatment?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, while NMDA receptor antagonists help regulate glutamate activity to prevent excitotoxicity. Dasatinib and Quercetin, currently under study, aim to reduce senescent cells, which are dysfunctional cells that accumulate with age and contribute to inflammation and tissue damage. Reducing these cells may alleviate some of the neuroinflammation and cellular dysfunction seen in Alzheimer's Disease, potentially slowing disease progression and improving cognitive function.

What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include hormone replacement therapy (HRT), anti-inflammatory drugs, and ginkgo biloba. HRT has been associated with an increased risk of developing dementia and cardiovascular events. Anti-inflammatory drugs, such as NSAIDs, have not shown significant benefits in slowing cognitive decline and can cause adverse events like gastrointestinal issues and cardiovascular risks. Ginkgo biloba is generally safe but has inconsistent evidence of benefit and lacks regulation, leading to variability in dosing and contents. For treatments like Dasatinib and Quercetin, which focus on reducing senescent cells, specific side effects are not detailed in the context, but general concerns with similar treatments include potential drug interactions and immune system effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on symptom management rather than disease modification. These include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which help improve cognitive function, and memantine, which regulates glutamate activity to support memory and learning. Recently, aducanumab, a monoclonal antibody targeting amyloid-beta plaques, was approved for its potential to slow disease progression. While there are no FDA-approved treatments specifically targeting senescent cells in Alzheimer's, ongoing research, such as the study of Dasatinib and Quercetin, aims to explore this novel approach.

What other types of research exist?

Promising novel alternatives to Dasatinib and Quercetin for Alzheimer's Disease patients include: 1) Anti-amyloid therapies such as Lecanemab and Donanemab, which target amyloid-beta plaques. 2) Tau-targeting therapies like TauRx's LMTX, which aim to reduce tau tangles. 3) Neuroinflammation modulators such as ALZT-OP1, which target inflammatory pathways. 4) Neuroprotective agents like BPN14770, which enhance synaptic function and cognitive performance. These therapies are in various stages of clinical development and may offer new avenues for treatment in 2024.

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Senolytic

Senolytics for Alzheimer's Disease

Phase 1 & 2

Waitlist Available

Led By Vijay K. Ramanan, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 11 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of Dasatinib, a cancer drug, and Quercetin, a plant compound, to help people over 55 with memory problems or Alzheimer's disease. The goal is to see if these drugs can safely remove damaged cells in the brain. By doing so, it might slow down or improve the symptoms of Alzheimer's disease. Dasatinib plus quercetin has been previously tested in an early-stage Alzheimer's disease study.

Who is the study for?

This trial is for men and women aged 55 or older with Mild Cognitive Impairment or Alzheimer's, confirmed by brain imaging showing Tau protein. They must not be on certain dementia medications or if they are, the dose should be stable for three months. Participants need a legal representative to consent and attend visits, have no major travel plans for about three months, and meet specific health criteria like adequate blood counts.

What is being tested?

The ALSENLITE study tests the combination of two drugs, Dasatinib and Quercetin, to see if they're safe and can work in people with Mild Cognitive Impairment (MCI) or Alzheimer's disease. The goal is to understand how these drugs affect cognitive impairment associated with Alzheimer's.

What are the potential side effects?

Potential side effects from Dasatinib may include fluid retention, bleeding problems, fatigue, digestive issues; while Quercetin could cause headaches and tingling sensations. Side effects vary between individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 11 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~11 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 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

Safety and Tolerability of 11 week of intermittent D+Q treatment

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Hypotension

Hypertension

Intracranial hemorrhage

Enterocolitis

Small intestinal obstruction

Lower gastrointestinal hemorrhage

Fungemia

Peripheral motor neuropathy

Typhlitis

Oropharyngeal pain

Multi-organ failure

Abdominal pain

Hypoxia

Diarrhea

Kidney infection

Edema limbs

Sinus bradycardia

Gastric hemorrhage

Myocardial infarction

Fibrinogen decreased

Aspiration

Atrial fibrillation

Delirium

Endophthalmitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dasatinib plus Quercetin Treatment GoupExperimental Treatment2 Interventions

Subjects with MCI or Alzheimer's disease will take Dasatinib and Quercetin by mouth at the same times for 2 days out of every 15 days for 6 cycles lasting for a total of 77 days (12 concurrent doses of each agent).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quercetin

2010

Completed Phase 4

~840

Dasatinib

2012

Completed Phase 3

~2320

Do I qualify?Apply below to find out

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 include cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, while NMDA receptor antagonists help regulate glutamate activity to prevent excitotoxicity. Dasatinib and Quercetin, currently under study, aim to reduce senescent cells, which are dysfunctional cells that accumulate with age and contribute to inflammation and tissue damage. Reducing these cells may alleviate some of the neuroinflammation and cellular dysfunction seen in Alzheimer's Disease, potentially slowing disease progression and improving cognitive function.

Exploring the Potential of Therapeutic Agents Targeted towards Mitigating the Events Associated with Amyloid-β Cascade in Alzheimer's Disease.