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

Russell Swerdlow

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: S-equol and Placebo; Drug: Placebo and S-equol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03101085

SEAD2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

S-equol First, Then Placebo

Other group

Description:

In this arm, participants receive S-equol 50mg twice daily for one month, followed by placebo twice daily for one month. There was no washout period.

Treatment:

Drug: S-equol and Placebo

Placebo First, Then S-equol

Other group

Description:

In this arm, participants receive placebo twice daily for one month, followed by S-equol 50mg twice daily for one month. There was no washout period.

Treatment:

Drug: Placebo and S-equol