Evidence map›Paper›PMID 28259590›Full record

Trial reportEBioMedicine2017

Efficacy and Blood Plasmalogen Changes by Oral Administration of Plasmalogen in Patients with Mild Alzheimer's Disease and Mild Cognitive Impairment: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.

Takehiko Fujino, Tatsuo Yamada, Takashi Asada, Yoshio Tsuboi, Chikako Wakana, Shiro Mawatari, Suminori Kono

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in EBioMedicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed
6.0field-weighted citation impact, top 3% 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

74 citing papers in PubMed, 141 citations in OpenAlex.

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14 more citing papers are in PubMed but not listed here.

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

7 authors at 4 institutions in 1 country.

Takehiko FujinoInstitute of Rheological Functions of Food, 2241-1 Kubara, Hisayama-machi, Kasuya-gun, Fukuoka 811-2501, Japan. Electronic address: fujino-t@boocsclinic.com.
Tatsuo YamadaGotanda Rehabilitation Hospital, 8-8-20 Nishigotanda, Shinagawa-ku, Tokyo 141-0031, Japan.
Takashi AsadaMemory Clinic Ochanomizu, 1-5-34, Yushima, Bunkyo-ku, Tokyo 113-0034, Japan.
Yoshio TsuboiDepartment of Neurology, School of Medicine, Fukuoka University, 7-45-1 Nanakuma, Johnan-ku, Fukuoka 814-0180, Japan.
Chikako WakanaBOOCS Clinic, 6-18 Tenya-machi, Hakata-ku, Fukuoka 812-0025, Japan.
Shiro MawatariInstitute of Rheological Functions of Food, 2241-1 Kubara, Hisayama-machi, Kasuya-gun, Fukuoka 811-2501, Japan.
Suminori KonoNational Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8636, Japan.
Institute of Rheological Functions of Food · JPFukuoka University · JPNational Institute of Infectious Diseases · JPOchanomizu University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlasmalogens (Pls) reportedly decreased in postmortem brain and in the blood of patients with Alzheimer's disease (AD). Recently we showed that intraperitoneal administration of Pls improved cognitive function in experimental animals. In the present trial, we tested the efficacy of oral administration of scallop-derived purified Pls with respect to cognitive function and blood Pls changes in patients with mild AD and mild cognitive impairment (MCI).

methodsThe study was a multicenter, randomized, double-blind, placebo-controlled trial of 24weeks. Participants were 328 patients aged 60 to 85years who had 20 to 27 points in Mini Mental State Examination-Japanese (MMSE-J) score and five or less points in Geriatric Depression Scale-Short Version-Japanese (GDS-S-J). They were randomized to receive either 1mg/day of Pls purified from scallop or placebo. The patients and study physicians were masked to the assignment. The primary outcome was MMSE-J. The secondary outcomes included Wechsler Memory Scale-Revised (WMS-R), GDS-S-J and concentration of phosphatidyl ethanolamine plasmalogens (PlsPE) in erythrocyte membrane and plasma. This trial is registered with the University Hospital Medical Information Network, number UMIN000014945.

findingsOf 328 patients enrolled, 276 patients completed the trial (140 in the treatment group and 136 in the placebo group). In an intention-to-treat analysis including both mild AD (20≤MMSE-J≤23) and MCI (24≤MMSE-J≤27), no significant difference was shown between the treatment and placebo groups in the primary and secondary outcomes, with no severe adverse events in either group. In mild AD patients, WMS-R improved significantly in the treatment group, and the between group difference was nearly significant (P=0.067). In a subgroup analysis of mild AD patients, WMS-R significantly improved among females and those aged below 77years in the treatment group, and the between-group differences were statistically significant in females (P=0.017) and in those aged below 77years (P=0.029). Patients with mild AD showed a significantly greater decrease in plasma PlsPE in the placebo group than in the treatment group.

interpretationOral administration of scallop-derived purified Pls may improve cognitive functions of mild AD.

fundingThe Japanese Plasmalogen Society.

Indexed as

Administration, OralAgedAged, 80 and overAlzheimer DiseaseCognitive DysfunctionFemaleHumansMaleMiddle AgedPlasmalogensPlasmalogensAlzheimer's diseaseCognitive functionMild cognitive impairmentPlasmalogenScallop

Identifiers

PMID28259590
PMCPMC5360580
OpenAlexW2591489876

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.