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

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Experimental ALS treatments, Antiplatelets, Anticoagulants

Disqualifiers: Pregnancy, Breastfeeding, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

100 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking experimental ALS treatments or antiplatelet or anticoagulant medications.

Research Team

Richard Bedlack, MD, PhD

Principal Investigator

Duke University

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Theracurmin 1 capsule (90mg) twice daily for 6 months

6 months

Virtual visits at baseline, month 1, and month 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Theracurmin HP

Participant Groups

Group I: Open Label Arm Experimental Treatment 1 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 Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Richard Bedlack, M.D., Ph.D.

Lead Sponsor

Trials

3

Recruited

180+