NCT02593318

Trial of Oxaloacetate in Alzheimer's Disease (TOAD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Russell Swerdlow · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if oxaloacetate (OAA) is safe and tolerable at doses of up to 2 grams per day in people with Alzheimer's disease (AD).

Detailed description

Alzheimer's disease (AD) is a progressive brain disorder that causes memory and thinking problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of your cells that produce energy) might be linked to symptoms of AD. Some studies have shown that the brains in patients with Alzheimer's disease have reduced mitochondrial activity, have fewer mitochondria present in the nerve cells, and have reduced ability to utilize glucose (sugar) for energy. Oxaloacetate (OAA) is a natural chemical that has been shown to have an effect on brain mitochondrial activity and brain energy in non-human animals. This study is divided into two parts. In the first part of the study, researchers will test whether a dose of 1 gram per day of OAA, taken for approximately 4 weeks in 15 people with AD is safe and tolerable. After all 15 participants in part 1 have completed their participation, and it is determined that the study drug was safe at this dose, the second part of the study will begin. In part 2, researchers will test a dose of 2 grams per day of OAA, taken for approximately 4 weeks in 15 people with AD, to assess safety at this dose. Participants will be in this study for about 10 weeks.

Conditions

• Alzheimer's Disease (AD)

Interventions

Type	Name	Description
DRUG	Oxaloacetate (OAA) 1g	Pills to be taken orally in 500mg dose two times per day
DRUG	Oxaloacetate (OAA) 2g	Pills to be taken orally in 1000mg dose two times per day.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2015-11-02
• Last updated: 2021-07-09
• Results posted: 2021-07-09

Locations

1 site across 1 country: United States