Clinical Trial: S-Equol in Alzheimer's Disease 2 Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Russell Swerdlow, MD

Current Primary Outcome: Difference in cytochrome oxidase/citrate synthase (COX/CS) activity [ Time Frame: One Month ]

Measured as the mean intra-individual COX/CS activity


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Safety of S-equol [ 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)
  • 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)
  • 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)
  • 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)
  • Stroop Test Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-unlimited (higher score indicates better result)
  • Determine if S-equol produces evidence of increase platelet mitochondria (COX) activity. [ 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.


Information By: University of Kansas Medical Center

Dates:
Date Received: March 29, 2017
Date Started: May 1, 2017
Date Completion: October 30, 2019
Last Updated: April 4, 2017
Last Verified: April 2017