@article{aed79f1275b046c3a01c15210555c664,
title = "Evaluation of the Feasibility, Safety and Efficacy of the Use of Intravenous Infusions of Adenosine Triphosphate (ATP) in People Affected by Moderate to Severe Alzheimer's Disease: A Double-Blind Masked Clinical Trial for Dose Finding",
abstract = "Background There are currently no drug therapies modifying the natural history of patients suffering Alzheimer's disease (AD). Most recent clinical trials in the field include only subjects in early stage of the disease, while patients with advanced AD are usually not represented. Objectives To evaluate the feasibility, safety and efficacy of systemic infusions of adenosine triphosphate (ATP) in patients with moderate to severe AD, and to select the minimum effective dose of infusion. Design A phase IIb, randomized, double-blind, placebo-controlled clinical trial investigates. Participants A total of 20 subjects with moderate or severe AD were included, 16 in the treatment group and 4 in the placebo group (4:1 randomization) at two dosage regimens, 6-hour or 24-hour infusions. Results The proof-of-concept study was successfully conducted, with no significant deviations from the study protocol and no serious adverse events reported. Regarding efficacy, only marginal differences were observed between ATP and placebo arms for H-MRS and MMSE variables. Conclusions Our study demonstrates that the use of ATP infusion as therapy is feasible and safe. Larger studies are however needed to assess the efficacy of ATP in moderate to severe AD.",
keywords = "A-BETA, AMYLOID-BETA, Alzheimer's disease, ENERGY, GENOME-WIDE ASSOCIATION, HYPOTHESIS, IDENTIFIES VARIANTS, LOCI, METAANALYSIS, METABOLISM, SYNTHASE, adenosine triphosphate, clinical trial",
author = "A. Ruiz and D. Sanchez and A. Lafuente and G. Ortega and M. Buendia and J. Papasey and S.Y. Jimeno and F.P. Badia and M.E. Palacio and C. Abdelnour and F. Ramirez-Torano and F. Maestu and M.E. Saez and L. Tarraga and P.C. Dagnelie and M. Boada",
note = "Funding Information: This work has been supported by the Direcci{\'o}n General the Farmacia. Instituto de Salud Carlos III (ISCIII). Ministerio de Innovacion Ciencia y Universidades. Gobierno Espa{\~n}a. Grant number EC11-358 and Fundaci{\'o} ACE. Funding Information: We would like to thank patients and controls who participated in this project. We are indebted to the Trinitat Port-Carb{\'o} legacy and her family for their support of Fundaci{\'o} ACE research programs. A. R. has received support from CIBERNED (Instituto de Salud Carlos III (ISCIII), the EU/EFPIA Innovative Medicines Initiative Joint Undertaking, ADAPTED Grant No. 115975, from EXIT project, EU Euronanomed3 Program JCT2017 Grant No. AC17/00100, from PREADAPT project. Joint Program for Neurodegenerative Diseases (JPND) Grant No. AC19/00097, and from grants PI13/02434, PI16/01861 BA19/00020, and PI19/01301. Acci{\'o}n Estrat{\'e}gica en Salud, integrated in the Spanish National RCDCI Plan and financed by Instituto de Salud Carlos III (ISCIII)- Subdirecci{\'o}n General de Evaluaci{\'o}n and the Fondo Europeo de Desarrollo Regional (FEDER - “Una manera de Hacer Europa”), by Fundaci{\'o}n bancaria “La Caixa” and Gr{\'i}fols SA (GR@ACE project). Funding Information: We would like to thank patients and controls who participated in this project. We are indebted to the Trinitat Port-Carb{\'o} legacy and her family for their support of Fundaci{\'o} ACE research programs. A. R. has received support from CIBERNED (Instituto de Salud Carlos III (ISCIII), the EU/EFPIA Innovative Medicines Initiative Joint Undertaking, ADAPTED Grant No. 115975, from EXIT project, EU Euronanomed3 Program JCT2017 Grant No. AC17/00100, from PREADAPT project. Joint Program for Neurodegenerative Diseases (JPND) Grant No. AC19/00097, and from grants PI13/02434, PI16/01861 BA19/00020, and PI19/01301. Acci{\'o}n Estrat{\'e}gica en Salud, integrated in the Spanish National RCDCI Plan and financed by Instituto de Salud Carlos III (ISCIII)- Subdirecci{\'o}n General de Evaluaci{\'o}n and the Fondo Europeo de Desarrollo Regional (FEDER - “Una manera de Hacer Europa”), by Fundaci{\'o}n bancaria “La Caixa” and Gr{\'i}fols SA (GR@ACE project). Publisher Copyright: {\textcopyright} 2022, Serdi and Springer Nature Switzerland AG.",
year = "2022",
month = jul,
doi = "10.14283/jpad.2022.38",
language = "English",
volume = "9",
pages = "425--434",
journal = "JPAD-Journal of prevention of alzheimers disease",
issn = "2274-5807",
publisher = "Editions SERDI",
number = "3",
}