drugset / Trial / NCT04044131
Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) Patients
Phase 2
Completed
120 enrolled
Istanbul Medipol University Hospital
Alanya Alaaddin Keykubat University · collabKTH Royal Institute of Technology · collabSahlgrenska University Hospital · collabScandiBio Therapeutics AB · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This double-blind, randomized, placebo-controlled, investigator-initiated, multi-centre trial aims to establish metabolic improvements in AD and PD subjects by dietary supplementation with cofactors N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside and serine. Concomitant use of pivotal metabolic cofactors via simultaneous dietary supplementation will stimulate to enhance hepatic β-oxidation and this study's hypothesis is that this will result in increased mitochondrial activity in human brain cell-types.
Timeline
- Start
- 2019-12-02
- Primary completion
- 2021-03-15
- Completion
- 2021-04-20
Publications
- Yulug B, Altay O, Li X, Hanoglu L, Cankaya S, Velioglu HA, Lam S, Yang H, Coskun E, Idil E, Bayraktaroglu Z, Nogaylar R, Ozsimsek A, Yildirim S, Bolat I, Kiliclioglu M, Bayram C, Yuksel N, Tozlu OO, Arif M, Shoaie S, Hacimuftuoglu A, Zhang C, Nielsen J, Turkez H, Boren J, Uhlen M, Mardinoglu A. Multi-omics characterization of improved cognitive functions in Parkinson's disease patients after the combined metabolic activator treatment: a randomized, double-blinded, placebo-controlled phase II trial. Brain Commun. 2025 Jan 6;7(1):fcae478. doi: 10.1093/braincomms/fcae478. eCollection 2025.
- Yulug B, Altay O, Li X, Hanoglu L, Cankaya S, Lam S, Velioglu HA, Yang H, Coskun E, Idil E, Nogaylar R, Ozsimsek A, Bayram C, Bolat I, Oner S, Tozlu OO, Arslan ME, Hacimuftuoglu A, Yildirim S, Arif M, Shoaie S, Zhang C, Nielsen J, Turkez H, Boren J, Uhlen M, Mardinoglu A. Combined metabolic activators improve cognitive functions in Alzheimer's disease patients: a randomised, double-blinded, placebo-controlled phase-II trial. Transl Neurodegener. 2023 Jan 26;12(1):4. doi: 10.1186/s40035-023-00336-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | L-carnitine | Other / unclassified | 3.73 g | Oral |
| Subject | N-acetylcysteine | Small molecule | 2.55 g | Oral |
| Subject | Nicotinamide riboside | Small molecule | 1 g | Oral |
| Subject | Serine | Unknown | 12.35 g | Oral |