ALS Reversals - Lunasin Regimen
ALS (Amyotrophic Lateral Sclerosis)
About this trial
This is an interventional treatment trial for ALS (Amyotrophic Lateral Sclerosis)
Eligibility Criteria
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.
- 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.
- Prior side effects from Lunasin.
- Known soy allergy.
- 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.
Sites / Locations
- Duke Medicine / Neurology
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Lunasin regimen
Historical controls
The Lunasin regimen consists of: LunaRich X Capsules (12 capsules per day) Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants' (3 scoops per day) Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids' (2 scoops per day) It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.
For each enrolled participant, matched historical controls will be identified from the PatientsLikeMe database. Participants will be matched according to their ALSFRS-R progression rate before they start on the Lunasin regimen (estimated by assuming their score was normal at 48 on the date of symptom onset).