DISAJP NEWS Vol. 40 July 4th, 2021 [ Is U.S. FDA ‘s approval for Aduhelm a good news? ]

Dementia Improved Support Association of Japan

This email is sent to those who subscribe DISA NEWS, the newsletter from the Dementia Improved Support Association of Japan.

We deliver the newsletter on the 4th of each month to bring you valuable information, aiming to achieve the dementia-free world.


〇 Is U.S. FDA ‘s approval for Aduhelm a good news ?

〇 Latest news on dementia and its prevention

〇 100 things by Dr. Hasegawa, the developer of HDS-R

〇 International mail delivery of KOUKA

〇 Is U.S. FDA ‘s approval for Aduhelm a good news ?

– Analysis : U.S. FDA faces mounting criticism over Alzheimer’s drug approval

In approving the first new Alzheimer’s drug in nearly 20 years, the U.S.

Food and Drug Administration is taking its biggest risk yet with a strategy that allows new therapies onto the market without strong evidence that they work, regulatory and scientific experts say.

The FDA has granted so-called “accelerated approval” in more than 250 instances since 1992, mainly for rare diseases or small patient populations that have had no effective treatments available to them. In these cases, the agency requires that drugmakers conduct additional clinical trials to prove their therapy works, or face withdrawal from the market.

Aduhelm, however, is in a different league in terms of the number of potential patients and cost to the healthcare system.

In addition, the FDA approval ignored the recommendation of its outside advisors, who said Biogen did not provide enough evidence of clinical benefit. Three of the advisory panel’s members have resigned in protest since the FDA decision was announced on Monday.

The FDA approval allows Biogen to sell its product over several years – with forecasts for potential annual sales reaching as high $10 billion to $50 billion – until the company completes a required follow-up study. (Excerpt)

In Japan, a new mutant of corona virus called Delta plus variant, also known as B. 6. 17. 2.1 or AY. 1, has been spreading out.
The variant is highly infectious and more likely to stick to alveoli. In India, it was designated as Variant of Concern.
Without succeeding in stopping the infection spread, Japan will have the Olympic Games from July 23 in Tokyo.
The event will take place without being canceled or held behind closed doors, apparently because of benefit for IOC or some stakeholders inside and outside the nation.
The same thing might go for the FDA’s approval. Financial support from the federal Medicare insurance program for seniors, surged stock price of the drug maker or huge hail by an advocacy organization UsAgainstAlzheimer’s could suggest that the campaign is driven by political motives rather than benefit to patients.

KOUKA is a processed food of Ganoderma lucidum. The ingredients are edible linseed oil, extract essence from Ganoderma lucidum, beer yeast (containing selenium), mackerel peptide DHA, EPA, fungus carbon powder (enzymatic decomposition product), dextrin (encapsulant), gelatin, glycerin, glycerol ester of fatty acid, and pullulan.

KOUKA is chemical free food. It is designed to deliver reishi essence and other substances that positively effect on cognitive functions to the brain through the blood-brain barrier. By improving microcirculation, it enhances oxygen and nutrition supply to the brain, as well as excretion of waste products from the brain.
Aduhelm might be able to remove brain plaques, but they might not be excreted.
KOUKA is physiologically functional to carry waste out of the brain.

〇 Latest news on dementia and its prevention

Here’s other global information on dementia and its prevention.

– The Creative Habit That Might Ward Off Dementia Symptoms,Even if You Start Later in Life

For a new meta-analysis published in the Journal of the American Geriatrics Society, researchers from the University of Pittsburgh examined nine studies with 495 participants over age 65 who have mild cognitive impairment (MCI) or dementia. The studies specifically evaluated older adults with MCI who took part in improvising music, playing existing music, singing, playing instruments, or other forms of music making.

The finding? Making music has a small but statistically significant effect on cognitive functioning, such as thinking and memory, says lead author Jennie L. Dorris, a Ph.D. student in rehabilitation science and a graduate student researcher in the University of Pittsburgh’s Department of Occupational Therapy.

– Can a Calculator Predict Your Risk of Dementia?

Can a Calculator Predict Your Risk of Dementia?

Canadian researchers at The Ottawa Hospital, the University of Ottawa, the Bruyère Research Institute and ICES have built and validated an online calculator that empowers individuals 55 and over to better understand the health of their brain and how they can reduce their risk of being diagnosed with dementia in the next five years.

“What sets this dementia risk calculator apart is that you don’t need to visit a doctor for any tests,” said Dr. Stacey Fisher, the lead author of the study who performed the research largely in Ottawa while she was a PhD student supervised by Dr. Doug Manuel and Dr. Peter Tanuseputro at The Ottawa Hospital.

〇 100 things by Dr. Hasegawa, the developer of HDS-R

At home and abroad, Dr. Kazuo Hasegawa, now 92, has enormously contributed to establishment of the groundwork for diagnosis of dementia.
In 2017, at the age of 88, he disclosed his disease.
After spending many years studying dementia, Dr. Hasegawa himself finally developed the disease.
He decided to make it public, because he wanted to let people know that anybody can have dementia.
And also, he wanted to make society more open to the disease.

Hoping to make it easier for those living with dementia to talk about the disease openly, he published a book titled I’m Enjoying my Spiritual Life with Dementia.
In the book Dr. Hasegawa shares 100 things he found.

31. It is important to build society where people can openly say “I’m living with dementia”, because nobody can live without any connection to others.

32. Keep in mind to pay attention to what you eat and take exercise.

33. There is a lot of evidence that fish is good for dementia.

34. It is not easy to keep it a habit to take exercise alone. Do it with others or have opportunities to share what you do.

35. There is a lot of misunderstanding about dementia due to lack of correct knowledge.

36. Dementia varies a lot. What the underlying disease is, where in the brain is damaged or how much the damage is also does.

37. It is not something they have but their “self” that people living with dementia lose.

38. Seeing somebody close to you losing intellectual resource or ability must be hard, but try to look at what he can do or what is left for him.

39. Nobody can be confident on the present and future without having any memory. That is why people living with dementia easily become anxious or irritated.

40. When people with dementia talk about their past, they are not just recalling what happened but also telling actual stories connected to the present, or possibly their future.

〇 International mail delivery of KOUKA

Japan Post announced to resume the operation of EMS to US, having been suspended due to spread of COVID-19, in June with increased charge.
The operation is already back in service to Europe and Asia.
Every overseas order for one package costs the total amount of 42,000JPY including the product’s price (39,000JPY) and EMS charge (3,000JPY).
We accept PayPal payment.
Don’t forget to check on the custom duty for your country before ordering.
The custom duty, if any, will be charged to the recipient.


We deliver further information at the official website.


DISAJP distributes valuable information on the 4th of each month to the world.
We welcome your feedback.

©2022 一般社団法人認知機能改善サポート日本協会