Clinical Study

Clinical Study

Clinical Study (RCT) of Plasmalogen (1)

Here, I’ll talk about our Randomized Controlled Trial to examine the effects of Plasmalogen on patients with mild Alzheimer’s disease and Mild Cognitive Impairment.

Study Design

Here is our study design. 328 patients, aged 60-85 years. They were randomized to receive either 1mg/day plasmalogens or placebo for 24 weeks. We assessed the safety to these patients by monthly clinic visit. Of 328 patients enrolled, 276 patients completed the 24- week follow-up.

Study Participants

Here is a breakdown of the study participants. Number of cases was 178 in Mild Cognitive Impairment, 98 in mild Alzheimer’s Disease.

Improvement of cognitive function in mild AD

The sub-analysis by sex and age in patients with mild Alzheimer’s Disease. Closed circle indicates Plasmalogen group, and open circle does placebo group, respectively. In female subjects, WMS-R, the marker of memory function, improved significantly in Plasmalogen group and there were significant differences between Plasmalogen and placebo groups as shown in the left panel. Right panel indicates the difference by age. In 77 or younger group, WMS-R significantly improved in Plasmalogen group and showed the significant differences between Plasmalogen and placebo groups.

Changes of Blood Plasmalogen

Here we did the sub-analysis by sex and age in patients with mild Alzheimer’s Disease. Closed circle indicates Plasmalogen group, and open circle does placebo group, respectively. In female subjects, WMS-R, the marker of memory function, improved significantly in Plasmalogen group and there were significant differences between Plasmalogen and placebo groups as shown in the left panel. Right panel indicates the difference by age. In 77 or younger group, WMS-R significantly improved in Plasmalogen group and showed the significant differences between Plasmalogen and placebo groups.

This slide shows the changes in plasma and erythrocyte Plasmalogen levels following oral administration of Plasmalogen. Closed circle indicates Plasmalogen group. Open circle shows placebo group. In the placebo group, Plasmalogen level in plasma significantly decreased at endpoint, and the significant difference between Plasmalogen and placebo groups was observed.

Clinical Study (Open-Label) of plasmalogen{2}

As for moderate and severe Alzheimer’s disease, we conducted an open-label trial.

Study Participants

Here is a breakdown of the study participants. The number of cases was 57 in moderate Alzheimer’s disease and 18 in severe Alzheimer’s disease.

Study Design

Here is our study design for an open-label trial. Participants received 1mg Pls orally per day for 3 months.

Improvement of cognitive function in moderate to severe AD

As shown in the left panel, 52.6 % of moderate AD improved significantly, while35.1% of those unchanged and 12.3% of those worsened. In severe AD, as shown in the right panel, 27.8% of those improved significantly. While 27.8% of those unchanged and 16.7% worsened.

Lastly, I will talk about discussion and conclusions. To our knowledge, this study is the first trial in the world that efficacy and change of blood plasmalogens by oral administration of plasmalogen were examined in patients with Alzheimer’s disease and mild cognitive impairment.

These results suggest that:

1) Oral administration of plasmalogen extracted from scallop improves cognitive functions in Alzheimer’s disease

2) Blood plasmalogen is useful for the assessment of cognitive functions, including the differentiation between Mild Cognitive Impairment and mild Alzheimer’s disease.

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