At a recent scientific conference, encouraging news about lecanemab — an amyloid-targeting monoclonal antibody investigated for the earliest stages of Alzheimer's disease — was presented and simultaneously published in the New England Journal of Medicine.

Data from the Phase 3 global clinical trial (CLARITY-AD) of lecanemab found that the drug reduced clinical decline compared with placebo at 18 months by 27% in individuals with mild cognitive impairment and mild Alzheimer's dementia. This data confirms this treatment changes the course of the disease in a meaningful way for people in the earliest stages of Alzheimer's. However, these benefits won't be realized if this treatment, if approved, is not accessible to those who need it.

The Alzheimer's Association supports Food and Drug Administration's (FDA) action to approve lecanemab and calls on the Centers for Medicare and Medicaid Services (CMS) to revise its restrictive coverage policy with the utmost urgency. Read the full statement from the Alzheimer's Association here.

Positive Treatment Data, Lecanemab Brings Hope and Enthusiasm

Part the Cloud Researchers Highlighted at Recent Conference

There is optimism and excitement in the field, and innovative grant funding programs like Part the Cloud have contributed greatly toward accelerating research. Part the Cloud explores the best research across multiple disciplines — tailoring treatments to the individual (precision medicine), repurposing drugs that work in other diseases, and exploring how cells communicate, age, clear debris and function. These are crucial areas to explore in better understanding this disease, and to move the drug pipeline forward to get potential treatments to patients sooner.

The Clinical Trials on Alzheimer's Disease (CTAD) conference recently took place in San Francisco. CTAD is focused entirely on Alzheimer's Disease therapeutic research — including clinical trials and also investigations into biomarkers and measurement methods — with the goal of data sharing and speeding the development of effective treatments.

Part the Cloud awardees are leading these conversations, and accelerating their innovative research forward. There were 5 oral presentations and 13 poster presentations by Part the Cloud-funded researchers that covered research advances that ranged from the safety and efficacy of new treatments in early phase trials, to using computerized games to lessen the decline in the earliest stages of the disease.

Five Part the Cloud funded researchers took the main stage to lead the scientific discourse.

KEYNOTE: Targeting Immuno-Metabolic Pathways in Alzheimer's Disease: Novel Mechanisms and Therapeutic Opportunities

Suzanne Craft, Ph.D., focused on the metabolic and immune changes that happen early on in the disease process. Her research is focused on intranasal insulin combined with other anti-diabetic drugs and has shown that this is a safe therapy, and leads to improvement in blood biomarkers of amyloid and tau ratios. The effects on the immune system and metabolic modulation in early stages of the disease —combined with lifestyle interventions—should be actively considered in combination therapy trials.

Read more about Dr. Craft's Part the Cloud funded research:

Alzheimer's Association awards grant to Wake Forest University School of Medicine for Alzheimer's research, Triad Business Journal

Suzanne Craft, Ph.D., Wake Forest University Health Sciences - Winston-Salem, NC

A Phase IIA Trial of Empagliflozin and Intranasal Insulin for MCI/AD

KEYNOTE: Precision Prevention of Dementia and Alzheimer's Disease: Advancing Multidomain Interventions

Miia Kivipelto, M.D., Ph.D., is a global leader in researching multi-domain lifestyle interventions to reduce the risk of dementia. Dr. Kivipelto is the primary investigator of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) and a co-lead of World Wide FINGERS with Dr. Maria Carrillo, which is a network of studies in more than 25 countries. In her keynote presentation, Dr. Kivipelto noted that the list of modifiable risk factors is getting longer and longer, and prevention can be seen as the key element to managing dementia. Protective factors like diet and exercise could delay cognitive decline in most individuals, and scientists are working to determine the optimum dose and intensity.  Importantly, those with genetic predisposition (APOE4 carriers) seem to have a clear benefit of this intervention, which means lifestyle interventions may postpone the influence of the genes.

Read more about Dr. Kivipelto's Part the Cloud funded project:

Miia Kivipelto, M.D., Ph.D., Imperial College — London, UK
Multimodal Lifestyle Intervention + Metformin to Prevent Cognitive Decline

Other Part the Cloud funded researchers featured at CTAD include:

Cerebrospinal Fluid Biomarker Effects From a Fixed-Dose Combination of Sodium Phenylbutyrate and Taurursodiol in Alzheimer's Disease: Results From the PEGASUS Trial

Steven Arnold, M.D. - Massachusetts General Hospital - Boston, MA
BCG Immunization Effects on Biomarkers of Inflammation/Immune Response and Alzheimer's Disease

Introduction to the Veri-T trial: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Verdiperstat in Patients with svPPA Due to FTLD-TDP 

Peter Ljubenkov, M.D., University of California, San Francisco — San Francisco, CA
Veri-T: A phase I Placebo-Controlled Trial of Verdiperstat in FTLD-TDP

Design of the ABCA1 agonist CS6253 Phase 1 SAD and MAD study in male and female, APOE4 and non-APOE4 carriers to assess safety, PK and biomarker efficacy

Jan Johansson, M.D., Ph.D., Artery Therapeutics, Inc. - San Ramon, CA
Human proof of concept of ABCA1 agonist CS6253 treatment

Five Things We Learned About Alzheimer's Disease in 2022

Thanks to innovative programs like Part the Cloud that accelerate high-risk, high-reward research, 2022 was a productive and promising year for Alzheimer's research, including discoveries related to the causes, risk factors and treatment of Alzheimer's disease and other dementias. Here are five important things we learned about Alzheimer's in 2022:

1. Alzheimer's treatments are getting better. As mentioned above, in November, pharmaceutical companies Eisai and Biogen announced positive results from their global Phase 3 clinical trial of an Alzheimer's drug called lecanemab, slowing the rate of cognitive decline in study participants by 27% over 18 months. These are the most encouraging results we have seen to date for an Alzheimer's treatment. A Food and Drug Administration (FDA) decision on accelerated approval is expected early in January 2022, potentially making lecanemab the second FDA-approved drug in 18 months that changes the course of Alzheimer's disease.
2. A daily multivitamin may slow brain aging. Research published in September in Alzheimer's & Dementia: The Journal of the Alzheimer's Association found that taking a multivitamin-mineral supplement every day for 3 years resulted in a statistically significant cognitive benefit. This is the first positive, large-scale, long-term study to show that multivitamin-mineral supplementation for older adults may slow cognitive aging. With confirmation through additional research, these promising findings have the potential to significantly impact public health — improving brain health, lowering health care costs,  and reducing caregiver burden — especially among older adults.
3. Frozen pizza, candy and soda may raise the risk of cognitive decline. At the Alzheimer's Association International Conference (AAIC) last summer, new research results found that eating a large amount of ultra-processed food can significantly accelerate cognitive decline. The research was then published in JAMA Neurology in December. Ultra-processed foods make up more than half of American diets. The good news is there are steps we can take to reduce risk of cognitive decline as we age. These include eating a balanced diet, exercising regularly, getting good sleep, staying cognitively engaged, protecting from head injury, not smoking and managing heart health.
4. Experiencing racism is linked to poor memory. Also at AAIC 2022, researchers reported that experiences of structural, interpersonal and institutional racism are associated with lower memory scores and worse cognition in midlife and old age, especially among Black individuals. These data are especially important given Black Americans are about twice as likely, and Hispanic Americans are about one and one-half times as likely, to have Alzheimer's or other dementias according to the 2022 Alzheimer's Disease Facts and Figures report.
5. Wearing hearing aids may reduce risk of dementia. Individuals with hearing loss who used hearing restorative devices had a 19% decrease in risk of long-term cognitive decline, according to research published in December in JAMA Neurology. These data appeared five months after the FDA announced it will allow hearing aids to be sold over the counter, greatly expanding access to 30 million Americans living with hearing loss. In addition to improving daily communication, use of hearing aids may also benefit brain health.

While advancements are happening, the significant impact of Alzheimer's remains. Over a recent 20-year period, deaths from heart disease went down 7.3%, while deaths from Alzheimer's increased 145%. In 2022, Alzheimer's and other dementias will cost the nation $321 billion.

With several FDA decisions expected on Alzheimer's treatments in 2023, this is a very exciting time in the fight to end this disease. Thanks to increased research funding from the federal government and nonprofit organizations there is great hope and the new year is sure to bring more advances and discoveries for people living with, or at risk for, Alzheimer's disease and all other dementia.

Part the Cloud: Alzheimer's Researcher Dr. Krista Lanctôt Focuses on How Brain Stimulation, Combined with Exercise, Benefits Cognition

Part the Cloud: Dr. Peter Ljubenkov Talks Dementia Research & Shares Personal Connection to Alzheimer's Disease