This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group.
This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group. Following informed consent and screening, participants with ALS will take Theracurmin 1 capsule (90mg) twice daily for 6-months. Treatment with the Theracurmin and all study outcome measures and labs are being performed exclusively for research purposes. Collected data includes saliva and stool microbiome sampling, adverse events, concomitant medications, weight and height, Theracurmin treatment evaluations, and Thrive Questionnaires. Participants will be asked to register on the website Patientslikeme.
Inclusion Criteria:
- Male or female, aged at least 18 years.
- Sporadic or familial ALS diagnosed as possible, laboratory-supported probable,
probable, or definite as defined by revised El Escorial criteria.
- Patient is able to understand and express informed consent (in the opinion of the site
investigator).
- Patient has access to the Internet on a desktop computer, laptop, or tablet and has a
working email address.
- Patient or caregiver is willing and able to use a computer and enter data on a secure
website.
- Patient is able to read and write English.
- Patient is expected to survive for the duration of the trial.
- 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)
- Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile,
or using adequate birth control methods) for the duration of the study and three
months after study completion. Adequate contraception includes: abstinence, hormonal
contraception (oral contraception, implanted contraception, injected contraception or
other hormonal contraception, for example patch or contraceptive ring), intrauterine
device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide,
or another adequate method.
Exclusion Criteria:
- Patient is taking other experimental treatments for ALS (those that are part of an
active research study).
- Prior side effects from curcumin or turmeric containing products
- Patient has a medical or psychiatric illness that could in the investigator's opinion
interfere with the patient's ability to participate in this study.
- Pregnant women or women currently breastfeeding.
- Life expectancy shorter than the duration of the trial.
- Taking an antiplatelet agent or anticoagulant (due to the theoretically increased risk
of bleeding from curcumin products).