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Trial record 30 of 450 for:    Recruiting, Not yet recruiting, Available Studies | "Alzheimer Disease"

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

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ClinicalTrials.gov Identifier: NCT03101085
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Ausio Pharmaceuticals, LLC
Information provided by (Responsible Party):
Russell Swerdlow, MD, University of Kansas Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: S-equol Other: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: S-Equol in Alzheimer's Disease 2 (SEAD2) Trial
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019


Arm Intervention/treatment
Experimental: S-equol
Participants will receive S-equol 50mg twice daily for one month
Drug: S-equol
S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules
Other Name: AUS-131

Placebo Comparator: Placebo
Participants will receive matched placebo pill to take twice daily for one month
Other: Placebo
Placebo capsules matched in size and color to S-equol capsules




Primary Outcome Measures :
  1. Difference in cytochrome oxidase/citrate synthase (COX/CS) activity [ Time Frame: One Month ]
    Measured as the mean intra-individual COX/CS activity


Secondary Outcome Measures :
  1. Safety laboratories evaluation and participant/study partner reporting of symptoms or adverse events [ Time Frame: Month 4 ]
    Measured as adverse events reported over the course of the study (safety labs, physical and neurological exams, vital signs, signs and symptoms)

  2. Montreal Cognitive Assessment (MoCA) Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-30 (higher score indicates better result)

  3. Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-70 (lower score indicates better result)

  4. Logical Memory Test (LMT) - immediate and delayed recall Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-25 (higher score indicates better result)

  5. Stroop Test Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-unlimited (higher score indicates better result)

  6. Pattern of COX activity changes while on the active treatment versus placebo arms of this crossover study. [ Time Frame: Months 1, 3, 4 ]
    Pts will categorically be defined as responders or non-responders depending on the slope of COS/CS activity change.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101085


Contacts
Contact: Annette Becker (913) 945-7674 abecker@kumc.edu
Contact: Rebecca Bothwell (913) 945-5033 rbothwell@kumc.edu

Locations
United States, Kansas
Clinical and Translational Science Unit Recruiting
Fairway, Kansas, United States, 66205
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Russell Swerdlow, MD
Ausio Pharmaceuticals, LLC
Investigators
Principal Investigator: Russell Swerdlow, MD University of Kansas Medical Center

Responsible Party: Russell Swerdlow, MD, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03101085     History of Changes
Other Study ID Numbers: SEAD2
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Equol
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs