2-HOBA for Prevention of Alzheimer's Disease

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 28
• Participant gender: All

Summary

To evaluate the administration of single doses of 2-HOBA in humans, with an escalation of doses that begins with the calculated Maximum Recommended Starting Dose. This evaluation will assess tolerability to oral administration of 2-HOBA, obtain pharmacokinetic data, characterize the 2-HOBA metabolic pathways, and determine the relation of dose to prevention of formation of bi-functional electrophile adducts in blood. Characterization of the metabolic fate of 2-HOBA will be supported by investigations that evaluate metabolism in microsomes, cells and other species.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University
• Collaborators: Metabolic Technologies Inc.; National Institute on Aging (NIA)
• Last Updated: 2017-06-26

Criteria

Inclusion Criteria:

• Healthy individuals between the age of 18 and 70

• Males and females who are post-menopausal or have had oophorectomies

• Not taking any medication 2 weeks prior to and during the study.

Exclusion Criteria:

• Inability to give informed consent

• Diseases that could manifest symptoms or signs that would confound interpretation of the relation between dietary ingredient action and potential adverse effects.

• Diseases that could manifest morbidity

• Known cardiac disease

• The need to discontinue any drug that is administered as standard of care treatment.