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Cytokine

Sargramostim for Alzheimer's Disease (SESAD Trial)

Phase 2

Recruiting

Led By Peter Pressman, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Have positive biomarker for brain amyloid pathology as shown by: Positive plasma assay for Aβ(42)/ Aβ(40) ratio AND Either positive CSF assay for AD assessment or positive amyloid PET, per PI read

Have a dedicated partner/caregiver informant who is in the company of the participant at least 12 hours a week, who can accompany them to scheduled visits, and who is able to provide accurate reporting upon the behavioral, cognitive and functional abilities of the participant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up informed consent to follow-up visit (38 weeks)

Awards & highlights

SESAD Trial Summary

This trial will test if a bone marrow stimulation medicine is safe and effective in Alzheimer's patients over six months.

Who is the study for?

This trial is for individuals aged 60-80 with mild-to-moderate Alzheimer's Disease, who have a caregiver available and meet specific cognitive criteria. They must not have certain medical conditions or be on treatments that could affect the study results.Check my eligibility

What is being tested?

The trial tests sargramostim, an FDA-approved drug for bone marrow stimulation, against a saline placebo to assess its safety and effectiveness in treating Alzheimer's over six months.See study design

What are the potential side effects?

Potential side effects of sargramostim may include allergic reactions, spleen enlargement, fluid retention issues like swelling or shortness of breath, blood disorders, and possible immune system changes.

SESAD Trial Eligibility Criteria

Inclusion Criteria

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

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My tests show positive signs of brain amyloid, indicating Alzheimer's.

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I have a caregiver who can be with me for at least 12 hours a week and attend visits.

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I am between 60 and 85 years old.

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My medications have been the same for the last 30 days.

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I have been diagnosed with mild or moderate Alzheimer's disease and my MoCA score is between 10-22.

SESAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ informed consent to follow-up visit (38 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~informed consent to follow-up visit (38 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and informed consent to follow-up visit (38 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety as measured by number of Adverse Events (AEs) by body system

Secondary outcome measures

Mini-Mental State Examination

Other outcome measures

Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog13)

Alzheimer's Disease Cooperative Study -Activities of Daily Living Inventory (ADCS-ADL)

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

+6 more

Side effects data

From 2021 Phase 4 trial • 87 Patients • NCT04326920

22%

Infectious disorder (not COVID-19)

15%

Constipation

Cardiac disorder

Epistaxis

Pneumonia

Thormboembolic event

Aspergillus infection

Respiratory failure

Hypoxia

Multi-bacterial bacteremia causing hemorrhagic shock

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

Active Sargramostim Treatment Group

SESAD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SargramostimExperimental Treatment1 Intervention

250 mcg/m2/day subcutaneously 5 days/week for 24 weeks

Group II: Placebo Control - SalinePlacebo Group1 Intervention

Placebo comparator (saline) subcutaneously 5days/week for 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sargramostim

2008

Completed Phase 4

~850

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,484 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,843 Total Patients Enrolled

Alzheimer's AssociationOTHER

91 Previous Clinical Trials

40,796 Total Patients Enrolled

Media Library

Sargramostim (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04902703 — Phase 2

Alzheimer's Disease Research Study Groups: Sargramostim, Placebo Control - Saline

Alzheimer's Disease Clinical Trial 2023: Sargramostim Highlights & Side Effects. Trial Name: NCT04902703 — Phase 2

Sargramostim (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04902703 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment still open?

"Confirmed. Clinicaltrials.gov records show that this experiment, which was initially posted on June 1st 2022 is presently enrolling individuals. 42 participants are needed from a single medical centre before the trial can begin."

Answered by AI

Has Sargramostim been authorized by the FDA?

"There is limited evidence of Sargramostim's safety, so it has been assigned a rating of 2. Clinical data confirming its efficacy does not yet exist."

Answered by AI

How many volunteers are partaking in this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that this medical trial, initially posted on June 1st 2022, is currently recruiting participants. 42 individuals are in need of recruitment from a single site."

Answered by AI

Does the trial extend to those aged sixty and above?

"This medical study is open to applicants between the ages of 60 and 80. For those younger than 18, there are 48 trials available while 643 studies cater for individuals over 65 years old."

Answered by AI

In what cases is Sargramostim typically employed?

"Sargramostim is frequently prescribed to combat acute myelocytic leukemia. It can also be employed for additional medical applications, such as allogenic bone marrow transplantation therapy, diarrhea relief, and post-operative recovery following general surgery."

Answered by AI

Has Sargramostim been tested in past scientific experiments?

"Presently 141 active trials utilising Sargramostim are being conducted with 30 of these studies in Phase 3. Although some of the experiments take place in Calgary, Alberta, there are 2269 locations around the globe running research on Sargramostim."

Answered by AI

Who meets the criteria to participate in this research study?

"Applicants must meet two key criteria in order to be eligible for this clinical trial: they must have alzheimer disease and fall between the ages of 60 and 80. Currently, 42 candidates are being considered."

Answered by AI