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 ]
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