Combination therapy with Nicotinamide and Pterostilbene for ALS patients

A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study. Extension Protocol

This study is testing a combination of two supplements, Nicotinamide and Pterostilbene, to see if they can help people with ALS feel better and slow down their disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 35 Years and up
• Sex: All
• Sponsor: Haukeland University Hospital (Academic / other)
• Locations: 17 sites (Bergen and 16 other locations)
• Trial ID: NCT05095571 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a combination therapy using Nicotinamide Riboside and Pterostilbene on patients with Amyotrophic Lateral Sclerosis (ALS). The aim is to determine whether this therapy can inhibit neurodegeneration, delay disease progression, and improve the quality of life for ALS patients. Participants will be those who completed the original NO-ALS study, and the study will monitor their health outcomes over time. The research is based on previous findings that suggest these compounds may enhance cellular metabolism and promote neuroprotection.

Who should consider this trial

Good fit: Ideal candidates are patients who have completed the original NO-ALS study and meet the inclusion criteria.

Not a fit: Patients with other neurodegenerative disorders or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly delay the progression of ALS and improve survival and quality of life for patients.

How similar studies have performed: Previous studies have shown promise in using similar approaches to enhance neuroprotection in neurodegenerative diseases, but this specific combination is novel.

Eligibility criteria

Inclusion Criteria:

* Patients who fulfilled the criteria for the NO-ALS study and have completed the study will be proposed inclusion in the NO-ALS extension study protocol. Patients from both arm 1 and arm 2 in the NO-ALS study will be allowed inclusion in the prolongation study

Exclusion Criteria:

Individuals will be excluded if any of the following exclusion criteria apply:

* Dementia, fronto temporal dementia (FTD) or other neurodegenerative disorder interfering with compliance.
* Metabolic, neoplastic, or other physically or mentally debilitating disorder.
* Patients who become tracheostomized as part of the treatment of ALS.
* Patients with short expected survival at the discretion of the investigator. Such cases cannot be expected to follow protocol procedures.
* Use of Vit B3 or blue berry extracts outside the study

Where this trial is running

Bergen and 16 other locations

• Haukeland University Hospital — Bergen, Norway (Recruiting)
• Nordlandssykehuset HF — Bodø, Norway (Not_yet_recruiting)
• Vestre Viken HF — Drammen, Norway (Not_yet_recruiting)
• Helse Førde HF — Førde, Norway (Not_yet_recruiting)
• Helse Fonna HF — Haugesund, Norway (Not_yet_recruiting)
• Sørlandet sykehus — Kristiansand, Norway (Not_yet_recruiting)
• Sykehuset Innlandet HF — Lillehammer, Norway (Not_yet_recruiting)
• Akershus University Hospital — Lørenskog, Norway (Not_yet_recruiting)
• Helse Møre og Romsdal — Molde, Norway (Not_yet_recruiting)
• Helse Nord-Trøndelag HF — Namsos, Norway (Not_yet_recruiting)
• Oslo Univerity Hospital — Oslo, Norway (Not_yet_recruiting)
• Sykehuset Østfold HF — Sarpsborg, Norway (Not_yet_recruiting)
• Sykehuset i Telemark HF — Skien, Norway (Not_yet_recruiting)
• Stavanger University Hospital — Stavanger, Norway (Not_yet_recruiting)
• Universitetssykehuset Nord-Norge — Tromsø, Norway (Not_yet_recruiting)
• St. Olavs Hospital HF — Trondheim, Norway (Not_yet_recruiting)
• Sykehuset i Vestfold HF — Tønsberg, Norway (Not_yet_recruiting)

Study contacts

• Principal investigator: Ole-Bjørn Tysnes — Haukeland University Hospital
• Study coordinator: Ole-Bjørn Tysnes

Conditions Amyotrophic Lateral Sclerosis