NCT03101085

S-Equol in Alzheimer's Disease 2 Trial

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Russell Swerdlow · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	S-equol and Placebo	S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules. The placebo is a matched pill that cannot be distinguished from the active S-equol.
DRUG	Placebo and S-equol	S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules. The placebo is a matched pill that cannot be distinguished from the active S-equol.

Timeline

• Start date: 2017-05-05
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2017-04-04
• Last updated: 2024-07-25
• Results posted: 2024-07-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study