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Completed

NCT Number: NCT03101085

S-Equol in Alzheimer's Disease 2 Trial

By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen in the body, causes an increase in mitochondrial activity. Researchers also hope to determine the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences cognition.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical and Translational Science Unit, Fairway, Kansas, United States

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About this study

Enrolled participants with a diagnosis of Alzheimer's Disease (AD) will be randomized to receive either S-equol or placebo first, and then cross over to receive the opposite intervention. The study, therefore, consists of two treatment periods with randomly assigned treatment order. Specifically, subjects are randomized to either: (1) S-equol for one month, then placebo for one month; or (2) placebo for one month, then S-equol for one month.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a diagnosis of Alzheimer's Disease (AD)
  • Have a study partner who has a close relationship with the participant and will attend study visits with the participant
  • Do not possess an Alkylphenol ethoxylates 4 (APOE4) variant of the APOE gene
  • Speak English as their primary language
  • Have not had any medication changes within the past 30 days

Exclusion criteria

  • Reside in a nursing home or dementia special care unit
  • Have a potentially confounding, serious medical risk such as insulin-requiring diabetes, any history of cancer that required a chemotherapy or radiation therapy intervention within the past 5 years, or a recent cardiac event
  • Have any clinically significant abnormal safety laboratory values at the SEAD2 screening visit
  • Have any clinically significant abnormal findings on vital signs measurements, or on physical or neurological examination at the SEAD2 screening visit
  • Use any type of systemic estrogen or testosterone replacement therapy
  • Has participated in another clinical trial or received any investigational drug or investigational therapy within 30 days before the screening visit

Treatment and study plan

S-equol and Placebo

Drug

S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules. The placebo is a matched pill that cannot be distinguished from the active S-equol.

Other names: S-equol is also called AUS-131

Placebo and S-equol

Drug

S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules. The placebo is a matched pill that cannot be distinguished from the active S-equol.

Other names: S-equol is also called AUS-131

Primary outcomes

  1. Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity

    Time frame: Column 1 is the value after completing S-equol minus the value after completing placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 COX/CS value. For placebo then S-equol, this is the Visit 4 minus the Visit 3 COX/CS value.

    Cytochrome oxidase (COX) was measured in platelet mitochondria as a pseudo-first order rate constant (sec-1/mg protein), which was determined as a Vmax, spectrophotometrically, by tracking the change in absorbance as reduced cytochrome c is oxidized to oxidized cytochrome C. Citrate synthase (CS) is a soluble mitochondrial matrix enzyme whose activity was determined spectrophotometrically as a Vmax (micromoles/mg protein). Reporting the COX activity as a ratio to CS activity takes mitochondrial mass into account, and normalizes the COX activity per the amount of mitochondria present in the assay sample, with units 1/(seconds multiplied by micromoles).

Secondary outcomes

  1. Pattern of COX Activity Changes While on the Active Treatment Versus Placebo Arms of This Crossover Study.

    Time frame: Visits 2, 3, 4

    Participants are defined as responders or non-responders depending on the slope of COX/CS activity change. Those in the "Responder" group have a greater slope of COX/CS activity change going from off- to on-S-equol as compared to going from on- to off-S-equol.

  2. Montreal Cognitive Assessment (MoCA)

    Time frame: Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 MoCA score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 MoCA score.

    Scale range: 0-30. A higher score indicates better global cognitive performance.

  3. Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11)

    Time frame: Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 ADASCog score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 ADASCog score.

    Scale range: 0-70. A lower score indicates better global cognitive performance.

  4. Logical Memory Test 1 (LMT1) - Immediate Recall

    Time frame: Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 LMT1 score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 LMT1 score.

    Scale range: 0-25. A higher score indicates better memory function.

  5. Logical Memory Test 2 (LMT2) - Delayed Recall

    Time frame: Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 LMT2 score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 LMT2 score.

    Scale range: 0-25. A higher score indicates better memory performance.

  6. Stroop Color Test Score

    Time frame: Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 Stroop Color Test score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 Stroop Color Test score.

    Scale range: 0-unlimited. A higher score indicates better executive function.

  7. Stroop Word Test

    Time frame: Score after completion of S-equol minus score after completion of placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 Stroop Word Test score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 Stroop Word Test score.

    Scale range: 0-unlimited. A higher score indicates better executive function.

  8. Stroop Interference Test

    Time frame: Score after completing S-equol minus score after completing placebo. For S-equol then placebo, this is the Visit 3 minus the Visit 4 Stroop Interference score. For placebo then S-equol, this is the Visit 4 minus the Visit 3 Stroop Interference score.

    Scale range: 0-unlimited. A higher score indicates better executive function.

  9. Number of Participants With Adverse Events

    Time frame: 4 Months: From Visit 1 (Day 0) through Visit 1 (end of month 1, +/- 7 days), Visit 2 (end of month 2, +/- 7 days), Visit 3 (end of month 3, +/- 7days), and Post-Interventions Phone Call (end of month 4, +/- 7 days)

    List of adverse events as reported over the course of the study (safety labs, physical and neurological exams, vital signs, signs and symptoms).

Sponsors and collaborators

Lead sponsor

Russell Swerdlow

Other

Collaborators

  • Ausio Pharmaceuticals, LLC

Registry information

Official study title

S-Equol in Alzheimer's Disease 2 (SEAD2) Trial

Acronym: SEAD2

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2017
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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