Clinical trial NCT03101085: S-Equol in Alzheimer's Disease 2 Trial
Official title: S-Equol in Alzheimer's Disease 2 (SEAD2) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alzheimer Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Ausio Pharmaceuticals, LLC
First posted: 2017-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 description: Enrolled participants with a diagnosis of Alzheimer's Disease (AD) will be randomized to receive either S-equol or placebo first, and then cross over to receive the opposite intervention. The study, therefore, consists of two treatment periods with randomly assigned treatment order. Specifically, subjects are randomized to either: (1) S-equol for one month, then placebo for one month; or (2) placebo for one month, then S-equol for one month.

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

Primary outcomes:
measure: Cytochrome Oxidase/Citrate Synthase (COX/CS) Activity
timeFrame: 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.
Secondary outcomes:
measure: Pattern of COX Activity Changes While on the Active Treatment Versus Placebo Arms of This Crossover Study.
timeFrame: Visits 2, 3, 4
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 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.
measure: Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11)
timeFrame: 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.
measure: Logical Memory Test 1 (LMT1) - Immediate Recall
timeFrame: 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.
measure: Logical Memory Test 2 (LMT2) - Delayed Recall
timeFrame: 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.
measure: Stroop Color Test Score
timeFrame: 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.
measure: Stroop Word Test
timeFrame: 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.
measure: Stroop Interference Test
timeFrame: 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.
measure: Number of Participants With Adverse Events
timeFrame: 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)
Other outcomes:
Locations:
city: Fairway
country: United States
facility: Clinical and Translational Science Unit
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Russell Swerdlow, MD
role: PRINCIPAL_INVESTIGATOR
References: