Trial · NCT03101085
S-Equol in Alzheimer's Disease 2 Trial
NCT03101085, Phase 1, Phase 2, Completed, Russell Swerdlow; results first posted 2024-07-17
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. S-Equol in Alzheimer's Disease 2 Trial. Trials, record NCT03101085. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03101085
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S-Equol in Alzheimer's Disease 2 Trial
- NCT number
- NCT03101085
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Russell Swerdlow
- Conditions
- Alzheimer Disease
- Interventions
- S-equol and Placebo, Placebo and S-equol
- First posted
- 2017-04-04
- Last updated
- 2024-07-25
- Results first posted
- 2024-07-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity | 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 | Pattern of COX Activity Changes While on the Active Treatment Versus Placebo Arms of This Crossover Study. | 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. |
| Secondary | Montreal Cognitive Assessment (MoCA) | 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. |
| Secondary | Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) | 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. |
| Secondary | Logical Memory Test 1 (LMT1) - Immediate Recall | 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. |
| Secondary | Logical Memory Test 2 (LMT2) - Delayed Recall | 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. |
| Secondary | Stroop Color Test Score | 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. |
| Secondary | Stroop Word Test | 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. |
| Secondary | Stroop Interference Test | 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. |
| Secondary | Number of Participants With Adverse Events | 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). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity | 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. | Due to the pandemic, 1 participant in the Placebo, Then S-equol group did not complete the analysis. This subject was excluded from this primary analysis, and all secondary analyses except for the safety analysis. As the order of the intervention does not matter, all 39 participants who contributed COX/CS data to the final analysis are included. The mean (SD) value reflects the mean of values obtained when the COX/CS value while on placebo was subtracted from the COX/CS score while on S-equol. | 1/(seconds multiplied by micromoles) | MEAN |
| SECONDARY | Pattern of COX Activity Changes While on the Active Treatment Versus Placebo Arms of This Crossover Study. | Visits 2, 3, 4 | Only the 20 participants who had baseline then S-equol then placebo values contributed to this analysis. | participants | NUMBER |
| SECONDARY | Montreal Cognitive Assessment (MoCA) | 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. | The one subject missing the COX/CS difference score was excluded from this analysis. The key measure is the difference score. Participants unable to contribute both S-equol and placebo scores were not included in the difference score analysis, but do contribute to the S-equol or placebo scores as available. | score on a scale | MEAN |
| SECONDARY | Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) | 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. | The one subject missing the COX/CS difference score was excluded from this analysis. The key measure is the difference score. Participants unable to contribute both S-equol and placebo scores were not included in the difference score analysis, but do contribute to the S-equol or placebo scores as available. | score on a scale | MEAN |
| SECONDARY | Logical Memory Test 1 (LMT1) - Immediate Recall | 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. | The one subject missing the COX/CS difference score was excluded from this analysis. The key measure is the difference score. Participants unable to contribute both S-equol and placebo scores were not included in the difference score analysis, but do contribute to the S-equol or placebo scores as available. | score on a scale | MEAN |
| SECONDARY | Logical Memory Test 2 (LMT2) - Delayed Recall | 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. | The one subject missing the COX/CS difference score was excluded from this analysis. The key measure is the difference score. Participants unable to contribute both S-equol and placebo scores were not included in the difference score analysis, but do contribute to the S-equol or placebo scores as available. | score on a scale | MEAN |
| SECONDARY | Stroop Color Test Score | 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. | The one subject missing the COX/CS difference score was excluded from this analysis. The key measure is the difference score. Participants unable to contribute both S-equol and placebo scores were not included in the difference score analysis, but do contribute to the S-equol or placebo scores as available. | score on a scale | MEAN |
| SECONDARY | Stroop Word Test | 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. | The one subject missing the COX/CS difference score was excluded from this analysis. The key measure is the difference score. Participants unable to contribute both S-equol and placebo scores were not included in the difference score analysis, but do contribute to the S-equol or placebo scores as available. | score on a scale | MEAN |
| SECONDARY | Stroop Interference Test | 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. | The one subject missing the COX/CS difference score was excluded from this analysis. The key measure is the difference score. Participants unable to contribute both S-equol and placebo scores were not included in the difference score analysis, but do contribute to the S-equol or placebo scores as available. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events | 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) | All 40 enrolled participants contributed to the safety data | participants | NUMBER |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity | Difference (on S-equol Minus on Placebo) | -0.0000049 | Standard Deviation 0.000024 | 1/(seconds multiplied by micromoles) | |
| Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity | S-equol | 0.0000195 | Standard Deviation 0.0000081 | 1/(seconds multiplied by micromoles) | |
| Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity | Placebo | 0.0000245 | Standard Deviation 0.0000258 | 1/(seconds multiplied by micromoles) | |
| Pattern of COX Activity Changes While on the Active Treatment Versus Placebo Arms of This Crossover Study. | S-equol Then Placebo Subjects Only | 7 | participants | ||
| Montreal Cognitive Assessment (MoCA) | Difference (on S-equol Minus on Placebo) | 0.2 | Standard Deviation 2.4 | score on a scale | |
| Montreal Cognitive Assessment (MoCA) | S-equol | 12.3 | Standard Deviation 6.3 | score on a scale | |
| Montreal Cognitive Assessment (MoCA) | Placebo | 12.0 | Standard Deviation 6.1 | score on a scale | |
| Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) | Difference (on S-equol Minus on Placebo) | 1.1 | Standard Deviation 5.5 | score on a scale | |
| Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) | S-equol | 24.6 | Standard Deviation 11.3 | score on a scale | |
| Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) | Placebo | 23.5 | Standard Deviation 10.6 | score on a scale |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | S-equol First, Then Placebo | 20 | |
| Overall Study | STARTED | Placebo First, Then S-equol | 20 | |
| Overall Study | COMPLETED | S-equol First, Then Placebo | 20 | |
| Overall Study | COMPLETED | Placebo First, Then S-equol | 19 | |
| Overall Study | NOT COMPLETED | S-equol First, Then Placebo | 0 | |
| Overall Study | NOT COMPLETED | Placebo First, Then S-equol | 1 |
Source ClinicalTrials.gov
Adverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Ear and labyrinth disorders | Prior to Starting Drug or Placebo | 0 | 40 | 0 |
| other | Dizziness | Ear and labyrinth disorders | While on S-equol | 0 | 40 | 0 |
| other | Dizziness | Ear and labyrinth disorders | While on Placebo | 0 | 40 | 0 |
| other | Dizziness | Ear and labyrinth disorders | After Completing Both Drug and Placebo | 1 | 40 | 1 |
| other | Food Allergy | Immune system disorders | Prior to Starting Drug or Placebo | 0 | 40 | 0 |
| other | Food Allergy | Immune system disorders | While on S-equol | 0 | 40 | 0 |
| other | Food Allergy | Immune system disorders | While on Placebo | 1 | 40 | 1 |
| other | Food Allergy | Immune system disorders | After Completing Both Drug and Placebo | 0 | 40 | 0 |
| other | Gastroesophageal Acid Reflux | Gastrointestinal disorders | Prior to Starting Drug or Placebo | 0 | 0 | 0 |
| other | Gastroesophageal Acid Reflux | Gastrointestinal disorders | While on S-equol | 1 | 40 | 1 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prior to Starting Drug or Placebo | 0 | 40 |
| Total, all-cause mortality | While on S-equol | 0 | 40 |
| Total, all-cause mortality | While on Placebo | 0 | 40 |
| Total, all-cause mortality | After Completing Both Drug and Placebo | 0 | 40 |
| Total, other adverse events | Prior to Starting Drug or Placebo | 1 | 40 |
| Total, other adverse events | While on S-equol | 8 | 40 |
| Total, other adverse events | While on Placebo | 8 | 40 |
| Total, other adverse events | After Completing Both Drug and Placebo | 4 | 40 |
| Total, serious adverse events | Prior to Starting Drug or Placebo | 0 | 40 |
| Total, serious adverse events | While on S-equol | 0 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03101085
GET https://conductscience.org/api/trials/v1/NCT03101085/results?page=2