Theracurmin for ALS

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Theracurmin HP, a form of curcumin (a compound in turmeric), to determine its potential benefits for people with Amyotrophic Lateral Sclerosis (ALS), a disease affecting nerve cells in the brain and spinal cord. Participants will take Theracurmin capsules twice daily for six months. The trial will compare results from people with ALS to healthy control participants to identify any differences. Individuals diagnosed with ALS who can use a computer and are not currently taking other experimental ALS treatments might be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that Theracurmin HP is likely to be safe for humans?

Research has shown that Theracurmin HP, a special type of curcumin, has been tested for safety in people. In earlier studies, healthy adults took doses similar to those planned for this trial, and the treatment was well-tolerated with no major side effects. Theracurmin HP is generally safe for regular use, but individuals with conditions like gallstones or bile duct problems should exercise caution.

Although earlier studies demonstrated the treatment's safety, this trial is still investigating its use for ALS. Prospective participants should consult healthcare professionals to ensure the trial is suitable for them.12345

Why do researchers think this study treatment might be promising?

Unlike the standard ALS treatments, which typically focus on managing symptoms or slowing disease progression through medications like riluzole and edaravone, Theracurmin HP offers a unique approach by utilizing curcumin, a compound derived from turmeric. Curcumin is known for its anti-inflammatory and antioxidant properties, which might provide new pathways for slowing ALS progression. Researchers are excited about Theracurmin because it uses an enhanced bioavailable form, making it easier for the body to absorb and potentially more effective at delivering these benefits. The hope is that it can offer a safer, more natural alternative with fewer side effects.

What evidence suggests that Theracurmin HP might be an effective treatment for mild cognitive impairment?

Research shows that Theracurmin, a type of curcumin, may help improve brain function. Studies have found that curcumin can enhance memory and attention in adults without dementia and is linked to better brain health related to memory. In this trial, participants in the experimental arm will receive Theracurmin HP to explore its potential effects on ALS. Although no direct evidence exists for its effects on ALS, the positive impact on brain function suggests it might help with conditions like ALS. The potential of curcumin to boost brain health offers hope for treating ALS symptoms.678910

Who Is on the Research Team?

RB

Richard Bedlack, MD, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Theracurmin HP
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Open Label ArmExperimental Treatment1 Intervention
Group II: Healthy Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
3
Recruited
180+

Citations

Study protocol to determine the effects of highly absorbable ...This trial will determine the effects of the highly absorbable oral curcumin (brand name: curcuRouge) on the indicators of cognitive functioning.
18-Month Study of Memory Effects of CurcuminThis project is designed to study the effects of the dietary supplement curcumin on age-related cognitive impairment. In particular, the study ...
Memory and Brain Amyloid and Tau Effects of a ...Daily oral Theracurmin may lead to improved memory and attention in non-demented adults. The FDDNP-PET findings suggest that symptom benefits are associated ...
Curcumin and Cognitive Function: A Systematic Review of ...This systematic review investigates the effect of curcumin on neurocognitive exams and inflammatory serum biomarkers in adults 18 years and older.
The effect of curcumin supplementation on cognitive functionSupplementation of curcumin can effectively improve global cognitive function, and the optimal dose and duration is 0.8g/day and ≥ 24 weeks.
Safety Data - Theracurmin® Clinical StudiesSafety evaluation of high bioavailability curcumin in Healthy Japanese Adults: A Randomized, placebo-controlled, double-blind, parallel-group comparison study.
Theracurmin® HPWarning. Do not take if you pregnant or nursing. If you have gallstone, a bile duct obstruction, or if you are taking any medications, consult a healthcare ...
Theracurmin® Bioavailable Curcumin PowderTheracurmin® is a safe material. Extensive toxicity and safety evaluations have been performed to validate the safety of Theracurmin®. Toxicity Data Clinical ...
Short-term effects of highly-bioavailable curcumin for treating ...We confirmed the safety of a Theracurmin dose of 150–210 mg that healthy humans could take in the phase 1 study.
Safety assessment of a highly bioavailable curcumin ...CGM can be considered as a safe curcumin supplement for regular consumption and is devoid of any adulterants or contaminants.
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