Evidence map›Paper›PMID 34988458›Full record

ArticleBMJ neurology open2021

Sodium selenate as a disease-modifying treatment for mild-moderate Alzheimer's disease: an open-label extension study.

Lucy Vivash, Charles B Malpas, Christopher M Hovens, Amy Brodtmann, Steven Collins, Stephen Macfarlane, Dennis Velakoulis, Terence J O'Brien

Open access · diamondAbstract read
In one paragraph

Article in BMJ neurology open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.2field-weighted citation impact, top 23% 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

9 citing papers in PubMed, 13 citations in OpenAlex.

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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

8 authors at 3 institutions in 1 country.

Lucy VivashDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.ORCID 0000-0002-1182-0907
Charles B MalpasDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
Christopher M HovensDepartment of Surgery, University of Melbourne, Melbourne, Victoria, Australia.
Amy BrodtmannDepartment of Neurology, Royal Melbourne Hospital, Parkville, Victoria, Australia.
Steven CollinsDepartment of Medicine and Radiology, University of Melbourne, Melbourne, Victoria, Australia.
Stephen MacfarlaneThe Dementia Centre, HammondCare, Melbourne, Victoria, Australia.
Dennis VelakoulisNeuropsychiatry Unit, Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Terence J O'BrienDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
The Royal Melbourne Hospital · AUThe University of Melbourne · AUDementia Collaborative Research Centres · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSodium selenate is a potential disease-modifying treatment for Alzheimer's disease (AD) which reduces hyperphosphorylated tau through activation of the protein phosphatase 2A enzyme. We have shown sodium selenate to be safe and well tolerated in a 24-week, phase 2a double-blind placebo-controlled randomised controlled trial (RCT), also reporting sodium selenate reduced neurodegeneration on diffusion-weighted MRI. This study assessed the safety and tolerability of chronic sodium selenate treatment (up to 23 months) in patients with AD who had been enrolled in the RCT. Cognitive measures served as secondary outcomes of potential disease-modification.

methodsAn open-label extension study of sodium selenate (10 mg three times a day) in patients with AD who had completed the previous RCT. Twenty-eight patients were enrolled. Patients were regularly monitored for safety, adverse events (AEs) and protocol compliance. Cognitive tests were administered for measures of disease progression.

resultsSixteen patients were discontinued by the sponsor, and 12 discontinued for other reasons. Treatment duration ranged from 6 to 23 months. The majority of AEs were mild (83%), and 33% were treatment-related. Common treatment-related AEs were alopecia (21%) and nail disorder (32%), which both resolved either prior to or following cessation of treatment. Two serious AEs occurred, which were not treatment-related. Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 score increased 1.8 points over 12 months. DISCUSSION: Chronic sodium selenate treatment is safe and well tolerated in patients with AD. Cognitive measures suggest a slowing of disease progression though this could not be confirmed as the study was not controlled. Further research into sodium selenate as a treatment for AD is warranted.

Indexed as

Alzheimer's diseasecognition

Identifiers

PMID34988458
PMCPMC8679123
OpenAlexW4200288195

What OpenQuestion holds

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LicenceCC BY-NC
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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.