What is ALCALS?
The randomized, double blind, placebo-controlled trial is testing whether a supplement called Acetyl-L-carnitine can help people living with ALS. Participants will be randomly assigned to take ALCAR at either one or two doses (1.5g/day or 3g/day) or a placebo. In addition to the standard treatment of riluzole. The participants and researchers will not know who is taking the real drug versus the placebo. The aim of the study is to see if ALCAR slows down the symptoms of ALS. This will be measured by a scale called ALSFRS-R.
The study will also look at:
- Breathing ability, cognitive function, and quality of life.
- Biological markers in the blood that may show how ALCAR works in the body
- Safety and side effects of ALCAR
Participants will be monitored for 48 weeks, with check-ins at 4, 12, 24, 36 and 48 weeks. After the conclusion of the study, participants will continue to be monitored until passing.
Eligibility Criteria:
- Age 18 or older
- ALS diagnosis according to Gold Coast Criteria
- Disease duration less than 24months from first ALS symptoms (limb weakness or bulbar symptoms) at base line.
- Self-sufficiency: adequate bulbar and spinal function (score ≥3 on ALSFRS-R for swallowing, cutting food/handling utensils, and walking).
- Respiratory function: FVC ≥80% of predicted.
- Progression of symptoms: documented via ALSFRS-R, with a disease progression rate (DFS) ≥0.33.
- Ability to understand and follow study requirements.
- Ability to give written informed consent (personally or via legally authorized representative).
- On riluzole 50 mg twice daily for at least 4 weeks before randomization.
- Intact cognitive function, as determined by the Principal Investigator.
- First qualifying ALS symptoms must involve weakness in extremity, bulbar, or respiratory muscles; cramps, fasciculations, or fatigue alone do not qualify.
| NSW | Concord Hospital | Julie Ryder 02 9767 8475 julie.ryder@health.nsw.gov.au |
Want to know more?
For more information visit Study Details | NCT06126315 | Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS | ClinicalTrials.gov