Evidence map›Paper›PMID 28854283›Full record

Trial reportPloS one2017

Transdermal rivastigmine for HIV-associated cognitive impairment: A randomized pilot study.

Jose A Muñoz-Moreno, Anna Prats, José Moltó, Maite Garolera, Núria Pérez-Álvarez, Crisanto Díez-Quevedo, Cristina Miranda, Carmina R Fumaz, Maria J Ferrer, Bonaventura Clotet and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.3field-weighted citation impact, top 47% 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

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Molecular mechanisms and therapeutic effects of different vitamins and minerals in COVID-19 patients.Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS) · 2022
    Review
  4. Observational
  5. Review
  6. Lithium's antiviral effects: a potential drug for CoViD-19 disease?International journal of bipolar disorders · 2020
    Review
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

11 authors at 5 institutions in 1 country.

Jose A Muñoz-MorenoFundació Lluita contra la SIDA (FLS), Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.ORCID http://orcid.org/0000-0002-7239-5422
Anna PratsFundació Lluita contra la SIDA (FLS), Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.
José MoltóFundació Lluita contra la SIDA (FLS), Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.
Maite GaroleraClinical Research Group for Brain, Cognition and Behavior, Consorci Sanitari Hospital de Terrassa, Terrassa, Catalonia, Spain.
Núria Pérez-ÁlvarezFundació Lluita contra la SIDA (FLS), Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.
Crisanto Díez-QuevedoDepartament de Psiquiatria i Medicina Legal, Universitat Autònoma de Barcelona (UAB), Cerdanyola del Vallès, Catalonia, Spain.
Cristina MirandaFundació Lluita contra la SIDA (FLS), Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.
Carmina R FumazFundació Lluita contra la SIDA (FLS), Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.
Maria J FerrerFundació Lluita contra la SIDA (FLS), Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.
Bonaventura ClotetFundació Lluita contra la SIDA (FLS), Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.
TRIANT-TE Study Group
Hospital Universitari Germans Trias i Pujol · ESUniversitat Autònoma de Barcelona · ESConsorci Sanitari de Terrassa · ESUniversitat de Vic - Universitat Central de Catalunya · ESUniversitat Oberta de Catalunya · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of transdermal rivastigmine for the treatment of HIV-associated cognitive impairment.

methodsWe recruited HIV-infected patients with cognitive impairment on stable antiretroviral therapy in a randomized controlled pilot trial with a 48-week follow-up. An additional assessment was held at 12 weeks. Participants received transdermal rivastigmine (9.5 mg daily), lithium (400 mg twice daily, titrated progressively), or remained in a control group (no new medication). The primary efficacy endpoint was change in a global cognitive score (NPZ-7). Secondary endpoints included change in specific cognitive measures, domains, and functional parameters. Safety covered the frequency of adverse events and changes in laboratory results.

resultsSeventy-six subjects were screened, and 29 were finally enrolled. Better cognitive outcomes were observed in all groups, although there were no significant differences between the arms (mean NPZ-7 change [SD]): rivastigmine, 0.35 (0.14); lithium, 0.25 (0.40); control, 0.20 (0.44) (p = 0.78). The rivastigmine group showed the highest positive trend (mean NPZ-7 [SD], baseline vs week 48): rivastigmine, -0.47 (0.22) vs -0.11 (0.29), p = 0.06; lithium, -0.50 (0.40) vs -0.26 (0.21), p = 0.22; control, -0.52 (0.34) vs -0.32 (0.52), p = 0.44. The cognitive domains with the highest positive trends were information processing speed at week 12 and executive function at week 48 (rivastigmine vs control): information processing speed, 0.35 (0.64) vs -0.13 (0.25), p = 0.17, d = 0.96; and executive functioning, 0.73 (0.33) vs 0.03 (0.74), p = 0.09, d = 1.18. No relevant changes were observed regarding functional outcomes. A total of 12 (41%) individuals dropped out of the study: 2 (20%) were due to medication-related effects in the rivastigmine group and 4 (36%) in the lithium group. No severe adverse events were reported.

conclusionsThe results from this small randomized trial indicate that transdermal rivastigmine did not provide significant cognitive benefits in people with HAND on stable antiretroviral therapy, even though positive trends were found in specific cognitive domains. Relevant tolerability issues were not observed.

Indexed as

Administration, CutaneousAdultAnti-Retroviral AgentsCognitive DysfunctionExecutive FunctionFemaleHIV InfectionsHumansLithiumMaleMiddle AgedNeuroprotective AgentsNeuropsychological TestsPilot ProjectsRivastigmineTreatment OutcomeAnti-Retroviral AgentsLithiumNeuroprotective AgentsRivastigmine

Identifiers

PMID28854283
PMCPMC5576750
OpenAlexW2753130661

What OpenQuestion holds

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LicenceCC BY
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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.