Evidence map›Paper›PMID 38093366›Full record

Trial reportAlzheimer's research & therapy2023

NeuroEPO plus (NeuralCIM

Saily Sosa, Giosmany Bringas, Nelky Urrutia, Ana Ivis Peñalver, Danay López, Evelio González, Ana Fernández, Zenaida Milagros Hernández, Ariel Viña, Yamile Peña and 7 more

Open access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Alzheimer's research & therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
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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

17 authors at 5 institutions in 1 country.

Saily SosaHospital Iván Portuondo, Calle 78 e/ Ave. 33 y 37, San Antonio de los Baños, Artemisa, CP 32 500, Cuba.
Giosmany BringasNational Institute of Neurology (INN), Calle 29 esquina D, Vedado, Havana, CP 10 400, Cuba.
Nelky UrrutiaHospital Iván Portuondo, Calle 78 e/ Ave. 33 y 37, San Antonio de los Baños, Artemisa, CP 32 500, Cuba.
Ana Ivis PeñalverNational Institute of Neurology (INN), Calle 29 esquina D, Vedado, Havana, CP 10 400, Cuba.
Danay LópezHospital Iván Portuondo, Calle 78 e/ Ave. 33 y 37, San Antonio de los Baños, Artemisa, CP 32 500, Cuba.
Evelio GonzálezCuban Neurosciences Center (CNEURO), Avenida 25, No. 15 007, Cubanacán, Havana, CP 11 600, Cuba.
Ana FernándezCuban Neurosciences Center (CNEURO), Avenida 25, No. 15 007, Cubanacán, Havana, CP 11 600, Cuba.
Zenaida Milagros HernándezCenter of Neurological Restoration (CIREN), Calle 216 esquina 13, Siboney, Playa, Havana, CP 11 600, Cuba.
Ariel ViñaCuban Neurosciences Center (CNEURO), Avenida 25, No. 15 007, Cubanacán, Havana, CP 11 600, Cuba.
Yamile PeñaCenter for Clinical Investigation, CENTIS, Calle 45 No. 4501, esquina a 34, Reparto Kolhy, Havana, CP 11 300, Cuba.
Juan Felipe BatistaCenter for Clinical Investigation, CENTIS, Calle 45 No. 4501, esquina a 34, Reparto Kolhy, Havana, CP 11 300, Cuba.
Carmen ValenzuelaInstitute of Cybernetics, Mathematics and Physics (ICIMAF), Calle 15 #551 entre C y D, Plaza de la Revolución, Vedado, Havana, CP 10 400, Cuba.
Kalet LeónCenter of Molecular Immunology (CIM), Calle 216 esquina 15, Siboney, Playa , Havana, CP 11 600, Cuba.
Tania CrombetCenter of Molecular Immunology (CIM), Calle 216 esquina 15, Siboney, Playa , Havana, CP 11 600, Cuba.
Teresita RodríguezCenter of Molecular Immunology (CIM), Calle 216 esquina 15, Siboney, Playa , Havana, CP 11 600, Cuba.
Leslie PérezCenter of Molecular Immunology (CIM), Calle 216 esquina 15, Siboney, Playa , Havana, CP 11 600, Cuba. leslie@cim.sld.cu.
ATHENEA Investigators
Center of Molecular Immunology (Cuba) · CUCuban Neuroscience Center · CUInstituto de Neurologia Y Neurocirugia · CUInternational Center of Neurologic Restoration · CUInstituto de Cibernética Matemática y Física · CU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeuroEPO plus is a recombinant human erythropoietin without erythropoietic activity and shorter plasma half-life due to its low sialic acid content. NeuroEPO plus prevents oxidative damage, neuroinflammation, apoptosis and cognitive deficit in an Alzheimer's disease (AD) models. The aim of this study was to assess efficacy and safety of neuroEPO plus.

methodsThis was a double-blind, randomized, placebo-controlled, phase 2-3 trial involving participants ≥ 50 years of age with mild-to-moderate AD clinical syndrome. Participants were randomized in a 1:1:1 ratio to receive 0.5 or 1.0 mg of neuroEPO plus or placebo intranasally 3 times/week for 48 weeks. The primary outcome was change in the 11-item cognitive subscale of the AD Assessment Scale (ADAS-Cog11) score from baseline to 48 weeks (range, 0 to 70; higher scores indicate greater impairment). Secondary outcomes included CIBIC+, GDS, MoCA, NPI, Activities of Daily Living Scales, cerebral perfusion, and hippocampal volume.

resultsA total of 174 participants were enrolled and 170 were treated (57 in neuroEPO plus 0.5 mg, 56 in neuroEPO plus 1.0 mg and 57 in placebo group). Mean age, 74.0 years; 121 (71.2%) women and 85% completed the trial. The median change in ADAS-Cog11 score at 48 weeks was -3.0 (95% CI, -4.3 to -1.7) in the 0.5 mg neuroEPO plus group, -4.0 (95% CI, -5.9 to -2.1) in the 1.0 mg neuroEPO plus group and 4.0 (95% CI, 1.9 to 6.1) in the placebo group. The difference of neuroEPO plus 0.5 mg vs. placebo was 7.0 points (95% CI, 4.5-9.5) P = 0.000 and between the neuroEPO plus 1.0 mg vs. placebo was 8.0 points (95% CI, 5.2-10.8) P = 0.000. NeuroEPO plus treatment induced a statistically significant improvement in some of clinical secondary outcomes vs. placebo including CIBIC+, GDS, MoCA, NPI, and the brain perfusion.

conclusionsAmong participants with mild-moderate Alzheimer's disease clinical syndrome, neuroEPO plus improved the cognitive evaluation at 48 weeks, with a very good safety profile. Larger trials are warranted to determine the efficacy and safety of neuroEPO plus in Alzheimer's disease.

trial registrationhttps://rpcec.sld.cu Identifier: RPCEC00000232.

Indexed as

Alzheimer DiseaseCognition DisordersCognitive DysfunctionActivities of Daily LivingAgedDouble-Blind MethodFemaleHumansMaleTreatment OutcomeAlzheimer’s diseaseNeuroEPONeuroprotectiveRandomized controlled trial

Identifiers

PMID38093366
PMCPMC10716956
OpenAlexW4389683409

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.