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Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) Patients

NCT04044131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-08-08

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease
  • Parkinson Disease

Interventions

DRUG

Metabolic Cofactor Supplementation

Dietary supplement consisting of serine, L-carnitine tartrate, N-acetylcysteine and nicotinamide riboside. Subjects in active treatment will receive dietary supplementation with N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside, and serine, administered as a mixture. Half dosage of the co-factors will be given for two weeks (one dose taken just after dinner), and full dosage for 8 weeks (two equal doses taken just after breakfast and dinner).

DRUG

Sorbitol

As placebo, sorbitol (5g) flavoured with strawberry aroma and colouring agent will be given.

Sponsors & Collaborators

  • ScandiBio Therapeutics AB

    collaborator INDUSTRY

  • Alanya Alaaddin Keykubat University

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • KTH Royal Institute of Technology

    collaborator OTHER

  • Istanbul Medipol University Hospital

    lead OTHER

Principal Investigators

  • Lutfu Hanoglu, MD, PhD · Medipol University

  • Burak Yulug, MD, PhD · Alanya Alaaddin Keykubat University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2021-03-15
Completion
2021-04-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044131 on ClinicalTrials.gov