S-Equol in Alzheimer’s Disease 2 (SEAD 2) Trial - Fairway, KS

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S-Equol in Alzheimer’s Disease 2 (SEAD 2) Trial - Fairway, KS


Study Status:
Recruiting
Age:
50 to 90
Duration:
4 months
Study Type:
Studies for People with Memory Impairment

Eligibility Requirements:

  • Have a diagnosis of Alzheimer's disease
  • Have a study partner who has a close relationship with the participant and will attend study visits with the participant
  • Have not had any medication changes within the past 30 days

About the Study:

Researchers believe mitochondria (the part of your cells that produces energy) might be linked to symptoms of Alzheimer’s. Some studies have shown that patients with Alzheimer’s have reduced mitochondrial activity or have fewer mitochondria present in neurons (a type of cell that helps to send and receive nerve impulses). In this study, it is believed that by targeting mitochondria, we might learn more about its influence on Alzheimer’s symptoms.

Purpose:

Studies have shown that estrogen (a female hormone) may improve mitochondrial function. S-equol is a drug that acts like estrogen does on mitochondria, but it lacks estrogen’s feminizing effects. The S-equol in Alzheimer’s Disease (SEAD) trial, which was completed here at KUMC in 2016, found that S-equol may increase mitochondrial function in participants with Alzheimer’s.

By doing this study we hope to learn if S-equol causes an increase in mitochondrial activity. We also want to see if this drug is safe to take, if it helps with thinking, and if it increases mitochondrial activity in blood cells of people with Alzheimer’s.
 

What is Involved:

In order to participate in this study, you must have a study partner, someone who knows you well, typically a spouse, friend, or relative, who is willing to:

  • Accompany you to all clinic visits
  • Be willing to answer questions regarding any changes in your health/ well-being and/or any changes in your medications
  • Ensure your study medication is taken as prescribed. 

Screening Phase:

You will first undergo a Screening Visit, at which time, all information that is needed to determine if you meet the treatment part of the study’s criteria is collected. During this visit, a study clinician will meet with you to discuss the APOE 4 gene, why you are being tested for the gene, and what impact learning you are an APOE 4 carrier or non-carrier may have for you and your family. 

Approximately one month later, all participants in this study are asked to return for a second visit. At this second visit, you will be told whether you are an APOE 4 carrier or non-carrier. If you are a carrier, you will not be told whether you carry one or two copies of the APOE 4 gene. Based on current research, it is expected that you will have about a 50% chance of having an APOE 4 version of the APOE gene. Any further questions you may have about your APOE genes will be answered. 

You will be asked to help us better understand mitochondrial activity and its potential relationship to thinking abilities and Alzheimer’s by undergoing some pen and paper thinking tests. These tests will take about 1 hour to complete. 

If you are found to be an APOE 4 carrier, your participation in this study will stop at that point. If you are found to be an APOE 4 non-carrier, you will undergo the same pen and paper thinking tests as the APOE 4 carriers, but you will also qualify to enroll in the study and receive the study treatment. If you enroll in the trial, you may continue to take any medications that you are currently taking for Alzheimer’s disease. 

Treatment Phase: 

If you are an APOE 4 non-carrier, you will enter the treatment phase of the study, which lasts approximately 2 months. You will be randomly assigned (like flipping a coin) to one of 2 groups. A computer will decide which group you are in. 

  • Group 1: Receive S-equol, 50mg twice daily between Visit 2 and Visit 3 and placebo between Visit 3 and Visit 4 

         OR 

  • Group 2: Receive Placebo between Visit 2 and Visit 3 and S-equol between Visit 3 and Visit 4.
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