What side effects are associated with this type of intervention?

Common treatments for Mild Cognitive Impairment (MCI) include cholinesterase inhibitors and memantine. Cholinesterase inhibitors can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine is generally well-tolerated but can occasionally lead to dizziness, headache, confusion, and constipation. Senolytic therapies, which are being studied for their potential in treating early-stage Alzheimer's disease, aim to selectively eliminate senescent cells. While specific side effects of senolytics are still under investigation, potential concerns include immune system modulation and off-target effects that could impact healthy cells.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically for the treatment of Mild Cognitive Impairment (MCI). Most treatments for cognitive decline focus on Alzheimer's disease, with cholinesterase inhibitors like donepezil and NMDA receptor antagonists like memantine being commonly used for Alzheimer's but not specifically approved for MCI. The SToMP-AD trial is exploring senolytic therapies, which aim to selectively eliminate senescent cells to potentially slow or modify disease progression in early-stage Alzheimer's disease, a novel approach not yet represented in existing FDA-approved treatments.

What other types of research exist?

Promising novel alternatives to Senolytics for Mild Cognitive Impairment (MCI) patients include: 1) Antisense Oligonucleotide Therapy, such as Tofersen for SOD1 ALS, which targets genetic mutations; 2) Emerging amyloid and tau targeting treatments, which aim to address the underlying pathology of Alzheimer's disease; 3) Calcitonin Gene-Related Peptide (CGRP) inhibitors, which have shown efficacy in migraine prevention and may have potential in cognitive impairment treatment. These therapies are in various stages of clinical trials and represent cutting-edge approaches to managing MCI.

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Senolytic

Senolytic Therapy for Alzheimer's Disease (SToMP-AD Trial)

Phase 2

Recruiting

Led By Suzanne Craft, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Must speak English fluently and have at least six years of formal education

Diagnosis of amnestic mild cognitive impairment (aMCI) or early Alzheimer's disease (AD)

Must not have

Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6 months

Inability to tolerate oral medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 48

Summary

This trial is testing drugs in older adults with early signs of cognitive decline and tau protein tangles in their brains. These drugs aim to remove old, damaged cells to reduce inflammation and other issues, potentially improving symptoms. The combination of dasatinib and quercetin has shown an acceptable safety profile in other conditions.

Who is the study for?

This trial is for adults aged 65 and older with mild cognitive impairment or early-stage Alzheimer's Disease, who have elevated tau protein levels. Participants must be on a stable dose of FDA-approved AD medications for at least three months, able to consent (or have a representative), and have a study partner. They should not plan extensive travel during the study and must speak English fluently.

What is being tested?

The SToMP-AD Study is testing the safety and effectiveness of senolytic therapy using Dasatinib plus Quercetin compared to placebo capsules in slowing down Alzheimer's progression in patients with positive tau PET scans.

What are the potential side effects?

Potential side effects may include changes in blood cell counts, liver or kidney function issues due to Dasatinib + Quercetin treatment. Specific side effects are not listed but will relate to the known profiles of these drugs.

Eligibility Criteria

Inclusion Criteria

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

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I speak English fluently and have completed at least six years of school.

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I have been diagnosed with early Alzheimer's or mild cognitive impairment.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a heart attack, chest pain, stroke, or mini-stroke in the last 6 months.

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I cannot take medicine by mouth.

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I am on blood thinners other than low-dose aspirin.

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I do not have major neurological conditions other than early Alzheimer's.

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I have been diagnosed with chronic heart failure.

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I am not on medications that strongly affect liver enzymes.

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I am currently on medication that includes chemotherapy drugs.

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My diabetes is not well-controlled, with HbA1c over 7% or I'm on insulin/sulfonylureas.

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My liver is not functioning well, with high bilirubin levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 48 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Serious Adverse Events (SAEs) and Adverse Events (AEs) in treatment group as compared to placebo group

Secondary study objectives

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

Change in Positron Emission Tomography (PET) - Computed Tomography (CT) - brain tau pathology

Change in cellular senescence blood marker Cluster of Differentiation 3 (CD3) in blood

+4 more

Side effects data

From 2023 Phase 1 & 2 trial • 5 Patients • NCT04063124

40%

Urinary tract infection

20%

Fall

20%

Diarrhea

20%

Hematuria

20%

Hypoglycemia

20%

Emesis

100%

80%

60%

40%

20%

Study treatment Arm

Intermittent D+Q

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Dasatinib (D) is given as (1) 100mg capsule daily for 2 consecutive days (Sprycel®, Bristol Myers Squibb). Quercetin (Q) will be given as (4) 250 mg capsules daily (total 1000 mg daily) for the same 2 consecutive days (Thorne Research). Both are administered orally.

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo capsules following the same administration protocol as the experimental treatment - administered once daily (1st dose of each cycle will be given, supervised, at the clinic visit; the 2nd dose will be taken at home) for 2 consecutive days followed by a 13-day (+/- 2 day) no-drug period for 12 consecutive weeks for 6 rounds of administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dasatinib + Quercetin

2016

Completed Phase 2

~40

0 / 12Eligibility 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

Senolytics are a class of drugs that selectively eliminate senescent cells, which are cells that have stopped dividing and contribute to aging and age-related diseases. By removing these dysfunctional cells, senolytics aim to reduce inflammation and improve tissue function, potentially slowing the progression of cognitive decline in Mild Cognitive Impairment (MCI) patients. This is particularly important for MCI patients as it addresses one of the underlying mechanisms of cognitive deterioration, offering a novel approach to preserving cognitive function and delaying the onset of more severe dementia.

New approaches to diagnose and treat Alzheimer's disease: a glimpse of the future.