Phase 2
Completed N=40
S-Equol in Alzheimer's Disease 2 Trial
Source: ClinicalTrials.gov NCT03101085 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity — -0.0000049; 0.0000195; 0.0000245 1/(seconds multiplied by micromoles) — p=>0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity |
-0.0000049; 0.0000195; 0.0000245 | >0.05 |
| SECONDARY Pattern of COX Activity Changes While on the Active Treatment Versus Placebo Arms of This Crossover Study. |
7 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
0.2; 12.3; 12.0 | — |
| SECONDARY Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) |
1.1; 24.6; 23.5 | — |
| SECONDARY Logical Memory Test 1 (LMT1) - Immediate Recall |
0.2; 4.1; 3.9 | — |
| SECONDARY Logical Memory Test 2 (LMT2) - Delayed Recall |
0.2; 1.9; 1.8 | — |
| SECONDARY Stroop Color Test Score |
-0.1; 40.0; 39.3 | — |
| SECONDARY Stroop Word Test |
-0.1; 56.1; 56.3 | — |
| SECONDARY Stroop Interference Test |
-1.2; 14.5; 15.3 | — |
| SECONDARY Number of Participants With Adverse Events |
1; 8; 8; 4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03101085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.