ALS Reversals - Lunasin Regimen

Study Overview
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Brief Summary
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This is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial utilizing a historical control group. Participants will receive a Lunasin regimen and will be asked to register for an account of PatientsLikeMe website, where after the initial in-clinic visit, they will be asked to enter specific data.

Detailed Description
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The primary hypothesis is that a supplement regimen containing Lunasin (referred to as the Lunasin regimen) can decrease the rate of ALSFRS-S progression by 50% relative to matched historic controls. ALS is a devastating motor neuron disease that causes rapidly progressive muscle weakness, disability and premature death. In spite of a large number of attempted ALS trials, there are no significant disease-modifying therapies for this condition. It was recently reported that a patient with a validated diagnosis of ALS, had experienced dramatic objective improvement in speech, swallowing and limb strength while taking a supplement regimen containing Lunasin. Several other patients with ALS have also reported improvement on this Lunasin regiment, though records were not obtainable to validate these. The Lunasin regimen will consist of: LunaRich X Capsules Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants' Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids' Dosages will be titrated up to target over the first 6 days. The subject will take the highest tolerated dosing for the remainder of the 12-month study. There are 3 in-clinic visits which occur at screening/baseline, Month 1 and Month 12. For Months 2-11, participants will make virtual visits by measuring their own ALSFRS-R score and weight and will record it in the PatientsLikeMe website. They will also self-report any perceived efficacy, compliance, adverse events and changes in concomitant medications.

Official Title
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An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)

Conditions
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ALS (Amyotrophic Lateral Sclerosis)

Intervention / Treatment
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* Drug: Lunasin Regimen
* Other: Historical control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lunasin regimen<br>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. | Drug: Lunasin Regimen<br>* LunaRich X Capsules, Reliv Now, ProVantage<br>|
| Active Comparator: Historical controls<br>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). | Other: Historical control<br>* Matched historical controls will be identified from the PatientsLikeMe database.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Revised ALS Functional Rating Scale (ALSFRS-R) | ALSFRS-R is a quickly administered (five minute) ordinal rating scale used to determine patient's assessment of their capability and independence in 13 functional activities. All 13 activities are relevant in ALS. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability, with a total score of 52 points. Reported is the rate of change in total points per month. | Screening/baseline - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in H3 Histone Acetylation | Participants, ALS controls (not on Lunasin) and healthy controls (not on Lunasin) had blood drawn at baseline and 1 month time points. Histones were extracted from blood cells. Western blots were used to look at specific histone acetylation patterns that Lunasin had reportedly altered in cell cultures (H3K9K14ac2 and H4K5K8K12K16). Integrated density values for AcH3 protein bands were normalized for total H3. Percent H3 values for the 1 month time point were normalized to that of the baseline visit. Results were analyzed by one-way ANOVA. | Screening/baseline, Month 1 | 
| Percent Agreement Between the Weights Obtained by Patients and Study Coordinator | To confirm that participants can accurately measure their own weight, even as they become more disabled by ALS, the investigators will compare the participant-generated weight with the weight obtained by the study coordinator at the Month 1 and Month 12 visits. A simple description of the accuracy (percent agreement between the weights) will be used. | Month 1, Month 12 | 
| Enrollment Rate | Rate of enrollment in reaching the 50 participants required to fill the trial. | Screening/baseline - Month 12 | 
| Retention Rate | Percentage of surviving participants who completed the month 12 visit. | Month 12 | 
| Frequency of ALS Reversals | The percentage of enrolled participants experiencing an ALSFRS-R improvement of at least 4 points lasting at least 12 months. | Screening/baseline - Month 12 | 
| ALSFRS-R Accuracy | To confirm that participants can accurately measure their own ALS Functional Rating Scale (Revised, ALSFRS-R), the investigators will compare the ALSFRS-R obtained by the coordinator with that obtained by the participants themselves at the Month 1 Visit. Correlational analysis between these 2 scores will be performed with Spearman's rho. | Month 1 |