Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)

Recruiting in Palo Alto (17 mi)

Overseen ByRichard Bedlack, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Richard Bedlack, M.D., Ph.D.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial will test Theracurmin capsules taken regularly over several months in people with ALS. Theracurmin may help by reducing inflammation and protecting cells from damage.

Eligibility Criteria

Inclusion Criteria

The patient can read and write in English.

Women must not be pregnant (will have evidence of a negative pregnancy test obtained by local physician within past 7 days or be post-menopausal).

The patient is able to understand what is happening during the surgery and can express informed consent, according to the site investigator.

+6 more

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Open Label ArmExperimental Treatment1 Intervention

The intervention is twice daily dosage of Theracurmin 90 mg capsules. This same dose was used in a successful trial of patients with mild cognitive impairment. Theracurmin HP capsules containing 90 mg curcumin each that will be taken as one capsule twice daily for 6 months. Each capsule contains 300 mg Theracurmin enhanced bioavailable water-dispersible turmeric rhizome complex providing 30% curcumin (90 mg). The content of Theracurmin HP has been independently certified by NSF International under NSF/ANSI 173.

Group II: Healthy Control ArmActive Control1 Intervention

We will seek to enroll 50 healthy control participants. We will attempt to enroll one control subject from each enrolled primary participant's home, preferably a spouse or partner of similar age if possible. We plan to use this data to compare the microbiome of control participants to that of the ALS participants at baseline, week 4 and month 6. We will not conduct further follow-up or collect additional samples with the control subjects.