Evidence map›Paper›PMID 36703196›Full record

Trial reportTranslational neurodegeneration2023

Combined metabolic activators improve cognitive functions in Alzheimer's disease patients: a randomised, double-blinded, placebo-controlled phase-II trial.

Burak Yulug, Ozlem Altay, Xiangyu Li, Lutfu Hanoglu, Seyda Cankaya, Simon Lam, Halil Aziz Velioglu, Hong Yang, Ebru Coskun, Ezgi Idil and 17 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Translational neurodegeneration, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04044131 (A Phase 2, Randomized, Placebo Controlled Study to Evaluate the Efficacy, Tolerability and Safety of Metabolic Cofactor Supplementation in Alzheimer's Disease), which is not on this map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed
12.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04044131 phase2completednot on this map

A Phase 2, Randomized, Placebo Controlled Study to Evaluate the Efficacy, Tolerability and Safety of Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) And Parkinson's Disease (PD) Patients

TypeinterventionalSponsorIstanbul Medipol University HospitalRan2019 to 2021Enrolled120ConditionsAlzheimer Disease, Parkinson DiseaseArmsMetabolic Cofactor Supplementation, Sorbitol
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 72 citations in OpenAlex.

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  6. A combined artificial intelligence-wet lab approach identifies a pivotal role of the NADAlzheimer's & dementia : the journal of the Alzheimer's Association · 2026
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  7. NADAlzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Review
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  15. Advances in the treatment of Alzheimer's disease.Frontiers in pharmacology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 10 institutions in 4 countries.

Burak Yulug *Department of Neurology and Neuroscience, Faculty of Medicine, Alanya Alaaddin Keykubat University, Antalya, Turkey.
Ozlem Altay *Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.
Xiangyu Li *Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.
Lutfu HanogluDepartment of Neurology, Faculty of Medicine, Istanbul Medipol University, Istanbul, Turkey.
Seyda CankayaDepartment of Neurology and Neuroscience, Faculty of Medicine, Alanya Alaaddin Keykubat University, Antalya, Turkey.
Simon LamCentre for Host-Microbiome Interaction's, Faculty of Dentistry, Oral and Craniofacial Sciences, King's College London, London, UK.
Halil Aziz VeliogluDepartment of Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.
Hong YangScience for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.
Ebru CoskunDepartment of Neurology, Faculty of Medicine, Istanbul Medipol University, Istanbul, Turkey.
Ezgi IdilDepartment of Neurology and Neuroscience, Faculty of Medicine, Alanya Alaaddin Keykubat University, Antalya, Turkey.
Rahim NogaylarDepartment of Neurology and Neuroscience, Faculty of Medicine, Alanya Alaaddin Keykubat University, Antalya, Turkey.
Ahmet OzsimsekDepartment of Neurology and Neuroscience, Faculty of Medicine, Alanya Alaaddin Keykubat University, Antalya, Turkey.
Cemil BayramDepartment of Medical Pharmacology, Faculty of Medicine, Atatürk University, Erzurum, Turkey.
Ismail BolatDepartment of Pathology, Veterinary Faculty, Ataturk University, Erzurum, Turkey.
Sena OnerDepartment of Molecular Biology and Genetics, Faculty of Science, Erzurum Technical University, Erzurum, Turkey.
Ozlem Ozdemir TozluDepartment of Molecular Biology and Genetics, Faculty of Science, Erzurum Technical University, Erzurum, Turkey.
Mehmet Enes ArslanDepartment of Molecular Biology and Genetics, Faculty of Science, Erzurum Technical University, Erzurum, Turkey.
Ahmet HacimuftuogluDepartment of Medical Pharmacology, Faculty of Medicine, Atatürk University, Erzurum, Turkey.
Serkan YildirimDepartment of Pathology, Veterinary Faculty, Ataturk University, Erzurum, Turkey.
Muhammad ArifScience for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.
Saeed ShoaieScience for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.
Cheng ZhangScience for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.
Jens NielsenDepartment of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.
Hasan TurkezDepartment of Medical Biology, Faculty of Medicine, Atatürk University, Erzurum, Turkey.
Jan BorénDepartment of Molecular and Clinical Medicine, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
Mathias UhlénScience for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden. mathias.uhlen@scilifelab.se.
Adil MardinogluScience for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden. adilm@scilifelab.se.
Atatürk University · TRScience for Life Laboratory · SEAlanya Hamdullah Emin Pasa University · TRErzurum Technical University · TRIstanbul Medipol University · TRKing's College London · GBAlanya Alaaddin Keykubat ÜniversitesiChalmers University of Technology · SEKTH Royal Institute of Technology · SESahlgrenska University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlzheimer's disease (AD) is associated with metabolic abnormalities linked to critical elements of neurodegeneration. We recently administered combined metabolic activators (CMA) to the AD rat model and observed that CMA improves the AD-associated histological parameters in the animals. CMA promotes mitochondrial fatty acid uptake from the cytosol, facilitates fatty acid oxidation in the mitochondria, and alleviates oxidative stress.

methodsHere, we designed a randomised, double-blinded, placebo-controlled phase-II clinical trial and studied the effect of CMA administration on the global metabolism of AD patients. One-dose CMA included 12.35 g L-serine (61.75%), 1 g nicotinamide riboside (5%), 2.55 g N-acetyl-L-cysteine (12.75%), and 3.73 g L-carnitine tartrate (18.65%). AD patients received one dose of CMA or placebo daily during the first 28 days and twice daily between day 28 and day 84. The primary endpoint was the difference in the cognitive function and daily living activity scores between the placebo and the treatment arms. The secondary aim of this study was to evaluate the safety and tolerability of CMA. A comprehensive plasma metabolome and proteome analysis was also performed to evaluate the efficacy of the CMA in AD patients.

resultsWe showed a significant decrease of AD Assessment Scale-cognitive subscale (ADAS-Cog) score on day 84 vs day 0 (P = 0.00001, 29% improvement) in the CMA group. Moreover, there was a significant decline (P = 0.0073) in ADAS-Cog scores (improvement of cognitive functions) in the CMA compared to the placebo group in patients with higher ADAS-Cog scores. Improved cognitive functions in AD patients were supported by the relevant alterations in the hippocampal volumes and cortical thickness based on imaging analysis. Moreover, the plasma levels of proteins and metabolites associated with NAD + and glutathione metabolism were significantly improved after CMA treatment.

conclusionOur results indicate that treatment of AD patients with CMA can lead to enhanced cognitive functions and improved clinical parameters associated with phenomics, metabolomics, proteomics and imaging analysis. Trial registration ClinicalTrials.gov NCT04044131 Registered 17 July 2019, https://clinicaltrials.gov/ct2/show/NCT04044131.

Indexed as

Alzheimer DiseaseCognitionDouble-Blind MethodHumansTreatment OutcomeAlzheimer’s diseaseCombined metabolic activatorsMulti-omicsSystems biologySystems medicine

Identifiers

PMID36703196
PMCPMC9879258
OpenAlexW4318195490

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.