LipiDiDiet, intervening on alzheimer’s before it is too late

Results of the European LipiDiDiet 1 clinical trial were published online today in the prestigious The Lancet Neurology, demonstrating how,
in people with prodromal stage Alzheimer’s disease, taking a once-daily multi-nutrient nutritional intervention
(Special Medical Purposes Food), while not improving the results of a specific neuropsychological test battery (NTB*), allows a significant
stabilization of cognitive and functional performance in daily life and a reduction in brain atrophy.
The nutritional intervention contains “Fortasyn Connect “**, a specific blend of essential fatty acids, vitamins and other nutrients.

LipiDiDiet, a project funded by the European Union’European Union

The LipiDiDiet study is part of a large research project funded by the European Union and involved 311 patients with Alzheimer’s disease
in the prodromal stage (also referred to as MCI, Mild Cognitive Impairment) in 11 centers in four countries (Finland, Germany, the Netherlands, and Sweden).
Patients were randomized to the multinutrient nutritional intervention for 24 months or an isocaloric control drink, to be taken for 24 months.

The primary endpoint of the study, the impact on NTB, was not met, as the decline in NTB in the control group was less than expected,
Making statistical analysis less valid.
In contrast, the main secondary endpoints demonstrated significant benefits for patients treated with the nutritional intervention in the study: a lower
worsening (45 percent) on the CDR-SB (Clinical Dementia Rating-Sum of Box) scale. CDR-SB is a particularly important scale, because it determines
the stage of disease progression by assessing practical activities of daily living, such as managing the home, finances, and important events.
In addition, less brain atrophy was found in the active group, with a difference of 26 percent for hippocampus and 16 percent for volume
ventricular, compared with the control group.

Progressive brain degeneration is typical of Alzheimer’s, and damage to the hippocampus is responsible for many of the memory problems associated with the disease.

Over the 24 months of analysis, the incidence of adverse events was similar in the active and control groups.

Hilkka Soininen, the statements

“The results published today in The Lancet Neurology are very important,” said Hilkka Soininen, professor of neurology at the University
from Eastern Finland and leading the clinical trial of the LipiDiDiet project, “as they bring us closer to understanding the effectiveness of nutritional interventions
in the prodromal stage Alzheimer’s disease, which we are now able to diagnose more accurately but cannot yet treat due to the lack of approved drugs.
LipiDiDiet study shows that this multinutrient drink can help preserve brain tissue, memory and patients’ ability to perform daily activities, the impairment of which is probably the most dramatic aspect of the disease”.

The LipiDiDiet study is the third clinical trial on this specific nutritional intervention to show favorable effects on memory.
Precedents were conducted on patients who had already developed mild Alzheimer’s dementia and showed that daily intake
of the multinutrient nutritional intervention resulted in a benefit on memory by improving measures of functional and synaptic connectivity in the brain.

Tobias Hartmann, statements

“Although this nutritional intervention cannot represent a cure for Alzheimer’s disease, it clearly shows that the sooner we intervene,
the greater the benefit to the patient,” said Tobias Hartmann, coordinator of the LipiDiDiet project.
“Importantly, the reduction in brain atrophy shows that the benefit is not just symptomatic. This result has never been achieved before.”.

Fortasyn Connect is the set of active nutrients contained in Souvenaid, in 125 ml package, to be taken once a day.
The nutrient blend has 20 years of study, starting with preclinical studies by prof. Kiliaan (Radboud University, Netherlands) and the LipiDiDiet projects
coordinated by prof. Hartmann (Saarland University, Germany), and funded by European Union research programs FP5 and FP7, as well as studies
of the prof. Wurtman (formerly of the Massachusetts Institute of Technology, USA), supported primarily by the US NIH, a research organization
governmental.

47 million people affected by Alzheimer’s disease

47 million people worldwide suffer from Alzheimer’s dementia, for which there is currently no cure. 2
Alzheimer’s has a long prodromal phase; the first symptoms of cognitive decline occur several years before the onset of dementia.
Many patients with early symptoms of the disease today may receive a diagnosis before the disease is established.
It is estimated that the number of people with Alzheimer’s will double every 20 years, reaching 74.7 million by 2030 and the 131.5 million in 2050.

*The NTB scale, is composed of different neuropsychological tests. In the Lipididiet study it included tests to assess episodic memory
(learning, remembering and recognizing a list of 10 frequently used names, CERAD-10 word list), semantics (category fluency) and aspects
functional subcortical (letter digit substitution test)

**Fortasyn Connect contains a mixture of nutrients, including omega-3 fatty acids, choline, uridine monophosphate, phospholipids, antioxidants and vitamin B.
It is a Special Medical Purpose Food for the diet of people with early-stage Alzheimer’s, with efficacy demonstrated through rigorous clinical trials