ApoE ε4 Alzheimer's Research: What's New and How YOU Can Accelerate Research

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"Why I Participate":

Here are some short (2-minute) videos from the U.S. National Institute on Aging (part of the U.S. National Institutes of Health) with real people who don't have Alzheimer's explaining why they participate in prevention research, providing information about their experiences and comments from their Study Doctors on the importance of their participation in advancing prevention and treatments.

Why I Participate in Alzheimer's Research - Kay's Story
Why I Participate in Alzheimer's Research - Bob's Story
Why I Participate in Alzheimer's Research - Kerretha's Story
Why I Participate in Alzheimer's Research - A Care Partner's story of Participation: Will's Story

Opportunities to Participate in Patient Registries and Observation Studies from 18-80+

Alzheimer's.Gov: Find Clinical Trials
  • Alzheimer's.Gov: Find Clinical Trialsis a service of the National Institute on Aging, and provides sections on what clinical research trials are, why they need health participants (especially for prevention trials) and how you can learn more.
ClinicalTrials.gov Observational Clinical Trials and Registries

These trials often need healthy volunteers to test new imaging or diagnostic tools, or seek to accelerate trial enrollment by providing people with the chance to take periodic "brain game" tests or answer questionnaires. Updated 1/17/2022

All of Us.
  • "All of Us is sponsored by the U.S. National Institute of Health and is "inviting one million people across the U.S. to help build one of the most diverse health databases in history. We welcome participants from all backgrounds. Researchers will use the data to learn how our biology, lifestyle, and environment affect health. This could help them develop better treatments and ways to prevent different diseases. Adults of any age are welcome! [/quote]
APT Web Study

APT Web Study is an innovative project of the Alzheimer's Clinical Trials Consortium (ACTC), a network of dozens of academic research centers collaborating to accelerate research, with funding from the U.S. National Institute on Aging. The APT Web Study is seeking for people who are 50 years or older and interested in accelerating AD research. Using an online, easy to use testing program that you can do on a laptop or tablet, they offer:

  • Access to secure, personalized, web-based tools to assess and track your cognitive performance
  • Opportunity to participate in comprehensive evaluations at one of our nationwide clinical sites
  • Opportunity to participate in clinical trials to prevent Alzheimer’s disease

You can view a brief video explaining the APT Web Study here.

Gene Match: Connecting Alzheimer's Prevention Studies With Eligible Volunteers

Gene Match: Connecting Alzheimer's Prevention Studies With Eligible Volunteers is a partnership in the U.S. led by the Banner Alzheimer's Institute and receives funding from the National Institute on Aging and NIH, the Alzheimer's Association, among others. It seeks to use genetic testing (a cheek swab kit sent to your home) to match volunteers with bot small and large trials. GeneMatch serves as the intermediary between researchers who may be looking for volunteers for online, or short-term research studies, particularly those with ApoE 4. All participation in voluntary; you simply receive an email about any studies for which you may be eligible and can then choose to get more information from the study organizers. The goal is to increase the number of studies that can recruit eligible participants, since up to 80% of studies are unable to find people to answer the research questions they have posed.

  • TrialMatch™ " is a service that provides customized lists of clinical studies based on user-provided information. The free, easy-to-use platform allows you to see which studies are a good fit for you or a family member. Search for studies, sign up for study updates, or connect with researcher teams.
  • As TrialMatch™ says: "Don't just hope for a cure — help us find one."

Clinical Trials Currently Recruiting with a focus on ApoE4

  • Note: We strongly recommend reading some of the sections below to learn more about clinical trials. The decision to contact any clinical trial site to begin the screening and enrollment process is a personal one that only you and a "study partner", if involved, can make. All clinical trial information may be changed by the trial sponsors or outside evaluates and studies may end with little to no advance notice.
  • The links provided below are from the ClinicalTrials.gov website. More tips on searching for clinical trials are listed below and by linking here: NIH ClinicalTrials.gov: Learn About Clinical Trials

Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) Recruiting amnestic MCI patients for "light therapy" in Boston, NYC and Orangeburg, NY; last updated August 3, 2021,==

Gene Therapy for APOE4 Homozygote of Alzheimer's DiseaseLocations NYC and Orlando, FL Last Updated June3, 2021

Imaging of Brain Structural/Functional Connectivity and Amyloid and Tau Lesions in APOE4 Carriers. (Protocol Z Recruiting from current registries at Washington Univ., St. Louis and Univ. of Southern California; Last Updated Oct. 14, 2021

Network-Level Mechanisms for Preclinical Alzheimer's Disease Development Last Updated Oct. 1, 2020

Prevention of Cognitive Decline in ApoE4 Carriers With Subjective Cognitive Decline After EGCG and a Multimodal Intervention ((PENSA) Location: Barcelona, Last Updated March 5, 2020

Hearing Aid and Individuals With Cognitive Disorders Requires hearing loss and AD diagnosis with ApoE4; locations Iowa and TN; last updated Feb. 25, 2020

DHA Brain Delivery Trial (PreventE4) Last Updated 2019; study continues through 2023; Location: USC-Los Angeles, CA)

[1] "The AHEAD Study tests whether an investigational treatment [BAN2401/lecanemab]can slow or stop the earliest brain changes due to Alzheimer’s disease in people with a higher risk of developing the disease later in life." Multiple US locations; also Australia and Canada, Last Updated Nov 24, 2021

Links to Recent Forum Topics on Alzheimer's-Related Clinical Research

This section aims to provide an easy way to browse some of the latest findings of research posted on the ApoE4.info forums, especially Science and Research and Prevention and Treatment that may be helpful to you and that were only possible through participation of people like ApoE4.info members.

Recent Advances in Lifestyle Prevention of AD/RD from Clinical Trials

  • Richard Isaacson, M.D. is Director of the Alzheimer's Prevention Clinic in NYC. In this 2018 review,Clinical Application of APOE in Alzheimer’s Prevention: A Precision Medicine Approach (2018) he and his team describe clinical trials that resulted in recommendations for targeted lifestyle interventions that are specific to APOE ε4 carriers. These include factors related to lifestyle, nutrigenomics (the effect of food on our genes), pharmacogenomics (the study of how our genes affect our responses to drugs), AD comorbidities (conditions associated with an increased risk of AD), and other biological and behavioral considerations. "Using a clinical precision medicine strategy that incorporates APOE ε4 carrier status may provide a highly targeted and distinct approach to AD prevention with greater potential for success." Here's what people like you who participated in research demonstrated about the benefits of physical activity in preventing Alzheimer's disease in ApoE4 carriers:
Physical activity
  • "A systematic review of 16 prospective studies concluded that physical activity decreased the risk of developing AD by 45%
  • "Physically active ε4 carriers had an OR [odds ratio risk of Alzheimer's] of 2.30 and sedentary ε4 carriers had an OR of 5.53
  • "Aerobic activity was associated with greater cognitive performance for ε4 carriers compared to non-carriers)".
  • "Sedentary individuals who were ε4 carriers had significantly higher levels of brain Aβ and lower levels of CSF Aβ42 compared to sedentary non-carriers, findings associated with AD pathology"
  • Dr. Isaacson notes that results of these studies with ApoE4 participants "have important implications for physical activity recommendations and suggest that increasing physical activity, while important for all AD prevention patients, may have more pronounced effects in ε4 carriers compared to non-carriers. The findings also suggest that physical activity may prevent Aβ accumulation that occurs in the brains of ε4 carriers before clinical symptoms of AD even become apparent

Flu, Pneumonia Vaccinations Tied to Lower Risk of Alzheimer's Dementia (July 2020)
Three research studies suggest that:

  • "At least one flu vaccination was associated with a 17% reduction in Alzheimer’s incidence. More frequent flu vaccination was associated with another 13% reduction in Alzheimer’s incidence."
  • "Vaccination against pneumonia between ages 65 and 75 reduced Alzheimer’s risk by up to 40% depending on individual genes."
  • "Individuals with dementia have a higher risk of dying (6-fold) after infections than those without dementia (3-fold)."
  • "With the COVID-19 pandemic, vaccines are at the forefront of public health discussions. It is important to explore their benefit in not only protecting against viral or bacterial infection but also improving long-term health outcomes,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “It may turn out to be as simple as if you’re taking care of your health in this way — getting vaccinated — you’re also taking care of yourself in other ways, and these things add up to lower risk of Alzheimer’s and other dementias,” Carrillo said. “This research, while early, calls for further studies in large, diverse clinical trials to inform whether vaccinations as a public health strategy decrease our risk for developing dementia as we age.”[Emphasis added.]

Blood Tests for Tau and Amyloid may replace need for PET scans and spinal taps and improve diagnosis July 2020'

  • A bit of background: Per Dr. Richard Isaacson of Cornell Weill Medicine's Alzeheimer's Prevention Program, "APOE ε4 carriers are at increased risk for developing AD and increased risk for developing the disease at an earlier age... Furthermore, studies have shown that individuals with two copies of the ε4 allele are at even greater risk, and the odds ratios for developing AD based on APOE is 5 times greater in APOE ε4 homozygotes [ApoE 4/4] compared to heterozygotes [ApoE 3/4 or 2/4]. Imaging studies have further supported these findings by demonstrating that APOE ε4 carriers have higher levels of brain amyloid-β (Aβ) and lower levels of CSF Aβ42 compared to non-carriers, findings that are associated with AD pathology. Clinical Application of APOE in Alzheimer’s Prevention: A Precision Medicine Approach (2018)===
  • A blood test for Alzheimer’s disease that incorporates both amyloid and tau measures may allow earlier and more accurate dementia diagnoses not only in research participants but also in patients referred to Memory Clinics for evaluation of possible cognitive impairment.
  • PET scans and spinal taps in healthy participants in clinical trials shows that not everyone with amyloid and tau develops AD/RD, BUT people with amyloid and tau are more likely to be diagnosed within 10-20 years with AD/RD.
  • As many as 30% of people in early studies of Alzheimer's may have had an incorrect diagnosis! Accurate blood tests to screen and monitor those at risk of AD/RD are crucial to finding ways to prevent, delay or treat these slow-moving diseases.
  • Scientists from St. Louis, Missouri launched the SEABIRD Study (Study to Evaluate Amyloid in Blood and Imaging Related to Dementia) (SEABIRD) "to develop and validate Alzheimer’s blood biomarkers in a cohort that is more diverse and representative of the greater St. Louis region. SEABIRD will enroll more than 1,100 individuals including diversity in race, socioeconomic status, medical history and cognitive status....they found that measuring levels of several different forms of p-tau in blood over time may enable clinicians and researchers to track the stages of Alzheimer’s progression in people living with the disease.

Alzheimer's Risk Factors May Be Measurable in Adolescents and Young Adults (2020)

  • Early Adult BMI (but not Late Life BMI) Associated With Late Life Dementia Risk
  • "Hgher early adulthood (age 20-49) body mass index (BMI) was associated with higher late-life dementia risk."
  • "Relatively little is known about the role of early life BMI on the risk of Alzheimer and other dementias....a total of 5,104 older adults from two studies, including 2,909 from the Cardiovascular Health Study (CHS) and 2,195 from the Health, Aging and Body Composition study (Health ABC), [of whom] 18% were Black and 56% were women {were studied].
  • "For women, dementia risk increased with higher early adulthood BMI. Compared to women with normal BMI in early adulthood, dementia risk was 1.8 times higher among those who were overweight, and 2.5 times higher among those who were obese."
  • They found no association between midlife BMI and dementia risk among women.
  • "For men, dementia risk was 2.5 times higher among those who were obese in early adulthood, 1.5 times higher among those who were overweight in mid-life and 2.0 times higher among those who were obese in mid-life, in models also adjusted for late life BMI."
  • For both women and men, dementia risk decreased with higher late life BMI.
  • Adina Zeki Al Hazzouri, Ph.D. of Columbia University and colleagues found that high BMI in adulthood is a risk factor for dementia in late life. The researchers suggest that efforts aimed at reducing dementia risk may need to begin earlier in life with a focus on obesity prevention and treatment.

Funding Areas in AD/RD Research through the U.S. National Institute on Aging

NIA-Funded Active Alzheimer’s and Related Dementias Clinical Trials and Studies Dec. 2020

  • Every year, the U.S. Congress approves funding for research into the epidemiology of Alzheimer's Disease (AD) and related dementia, including Parkinson's disease (PD), Lewy body Dementia (LBD, Frontal Temporal Dementia (FTD), vascular dementia (VD) and mixed dementia (Alzheimer's with one or more other dementias). As of early 2021, funding for Alzheimer's and dementia related research at the National Institutes of Health (NIH) is $3.1 billion, following an additional $300 million increase for fiscal year 2021. This is more than double the amount budgeted as recently as 2016. Alzheimer's Impact. Movement
  • The National Institute on Aging (NIA) is currently supporting 272 active clinical trials on Alzheimer’s disease and related dementias. NIA’s active trials include: early-stage clinical drug development, late-stage clinical drug development, non-pharmacological interventions, clinical therapy development for neuropsychiatric symptoms of dementia, and care and caregiver interventions. For more information on each of these ares, see this December 2020 list with detailed links in each area: NIA Ongoing AD Clinical Trials

What is a Randomized Control Trial (RCT) or Double-Blind Trial and Why Does It Include a Placebo Group?

  • If you've read about "gold standard" clinical trials, often called RCTS, you may have wondered what makes them different from just giving some people an exercise program, a supplement, a brain-training app, mindfulness training, or a drug under study and then seeing how they do compared to their performance before the intervention. You may also have wondered why you would join a clinical trial if you might be given only a placebo. The NIA wants people to be well-informed about their participation and the reasons for decisions in clinical trials. Here's an excerpt from their website: NIA: Placebo in Clinical Trials
  • "In undertaking a clinical trial, researchers don’t want to leave anything to chance. They want to be as certain as possible that the results of the testing show whether or not a treatment is safe and effective. The “gold standard” for testing interventions in people is the “randomized, placebo-controlled” clinical trial. That means volunteers are randomly assigned—that is, selected by chance—to either a test group receiving the experimental intervention or a control group receiving a placebo or standard care. A placebo is an inactive substance that looks like the drug or treatment being tested...in many trials, no one—not even the research team—knows who gets the treatment, the placebo, or another intervention. When participants, family members, and staff all are “blind” to the treatment while the study is underway, the study is called a “double-blind, placebo-controlled” clinical trial.Randomized, placebo-controlled clinical trials (RCTs)
  • "In many trials, no one—not even the research team—knows who gets the treatment, the placebo, or another intervention. When participants, family members, and staff all are “blind” to the treatment while the study is underway, the study is called a “double-blind, placebo-controlled” clinical trial."
  • Note: The "arms" of a trial don't have to be 50% percent placebo and 50% intervention; the design is determined with the help of biostatisticians. Because researchers know the expected effects of a "placebo", the arms may be 2/3 on Intervention and 1/3 placebo, or 1/3 on 50 mg. day of Study Drug; 1/3 on 25 mg/day of study drug and 13 on placebo
  • "Test and placebo groups are equally important, as shown by the results of numerous clinical trials. For example, early research suggested that ginkgo biloba, an herbal supplement, might be effective in delaying dementia. To find out, the National Institutes of Health (NIH) sponsored a 6-year, Phase 3 clinical trial with more than 3,000 participants age 75 and older. At the end of the trial, scientists reported that they had found no significant differences in effect on dementia in adults who received ginkgo biloba or the placebo. This result was disappointing, but scientists gained a wealth of information to inform future research. Based on the results of this and other trials in people with Alzheimer’s, scientists have begun to test treatments in people at earlier stages of disease— that is, people who may have Alzheimer’s-related brain changes but no memory loss or other symptoms. Many researchers think that treatment earlier in the disease process may help prevent or delay dementia.

Underserved and Underrepresented Communities in ApoE 4/Alzheimer's Research

Forget Me Not: Alzheimer's and the Black/African-American Community

  • Click on the link above to watch a 3 minute video from UsAgainstAlzheimers/African-Americans Against Alzheimers to hear from family members, caregivers, journalists, and researchers about the need to raise awareness, engagement, support and participation in clinical trials with Black communities.
  • Alzheimer's is the 4th leading cause of death among older African Americans.
  • 20% of Americans with the disease are African Americans, and they bear 33% of its national cost.
  • Overall, Alzheimer's clinical trials only have 3% of Black participants. As one researcher notes: Recommendations are made on who participates in clinical trials. All communities need to be represented to have valid recommendations. That may be especially true for Apoe4 carriers who are Black, since it appears that the effects of APoE4 may be different within African populations and between African, Caribbean-African and African-American populations.

LatinosAgainst Alzheimer's: Latinos & Alzheimer’s Disease: New Numbers Behind the Crisis

  • "While Latinos make up 17% of the U.S. population, they make up less than 1% of participants in all National Institutes of Health clinical trials. Further, Latinos make up just 7.5% of research participants across the approximately 32 Alzheimer’s Disease Research Centers (ADRCs) funded by NIH. Latino volunteers are needed to help researchers understand and develop treatments and health interventions for AD that work for all ethnic groups.... Further, recruitment strategies and trial designs should better reflect the needs and realities of Latino communities."
  • Our Mind: Investigation About Alzheimer’s Disease in the Latino Community (video in English.
  • ¿Qué le pasa a mi memoria? (Video in Spanish.

Collaborative Approach for Asian Americans & Pacific Islanders Research & Education Registry

  • The Center on Aging: Connecting with Asian-American and Pacific Islanders About Dementia reports that "Asian Americans and Pacific Islanders (AAPI) are the fastest growing minority group in America.
  • Between 2010 and 2030, the AAPI older adult population is projected to increase by 145%.1 As this aging population rapidly increases, AAPI older adults face a public health crisis similar to older adults from other ethnic backgrounds, as age is the largest risk factor for Alzheimer’s disease. The prevalence and incidence of Alzheimer’s disease and related dementias within AAPI communities is not well understood.
  • Limited disaggregated research unveils that Vietnamese older adults have a disproportionately high prevalence of cognitive problems (16.6%), more than double the rate for Koreans at 7.6%. Native Hawaiians and Pacific Islanders have a higher risk of cognitive issues and activities of daily living impairments, which is two times the risk as compared to Chinese older adults."
  • NOTE: If you or someone you know is a member of the AAPI community, please share this National Institute on Aging (NIA)-sponsored registry link with them, so that this under-represented community may benefit from AD clinical research: Collaborative Approach for Asian Americans & Pacific Islanders Research & Education Registry

Genome-Sharing Resources

  • The Personal Genome Project at Harvard began in 2005 and is now a member of the Network of Personal Genome Projects that has grown to include researchers at many leading institutions around the globe. According to the PGP "Open data is a critical component of the scientific method, but genomes are both identifiable and predictive, so many studies don’t share their data. The PGP is a unique resource of public human data that allows open collaborative research on human genomes and biology. Donating your genome and health data to science is a great way to enable advances in understanding human genetics, biology, and health. We seek volunteers willing to donate diverse personal information to become a public resource."
  • OpenSNP "allows customers of direct-to-customer genetic tests to publish their test results, find others with similar genetic variations, learn more about their results by getting the latest primary literature on their variations, and help scientists find new associations."

NIH ClinicalTrials.gov: Learn About Clinical Trials

The NIH has a searchable database with information about clinical trials on many subjects, across many countries, including those funded by governments, academic research centers, non-profit organization, and private companies. You can get a good sense of what is involved in a clinical trial and what questions to ask if you volunteer to be screened for participation here: [https://clinicaltrials.gov/ct2/about-studies/learn NIH ClinicalTrials.gov: Learn About Clinical Trials

  • To see the wide range of clinical trials currently or soon-to-be recruiting participants, try this link, which is updated as of Feb. 2021: Clinical Trials Alzheimer's Trials Currently Recruiting Participants
  • If you'd like to search in your specific city or state, or by a certain condition (ex. Mild Cognitive Impairment, Healthy Volunteers, age range) or type of study (observational, interventional) use the Advance Search function here: Clinical Trials: Advanced Search Function
  • To find studies (of all types) in your country, state, province or region, click on Clinical Trials: Interactive Map Display and then on the location of interest (ex. clicking on the map of the U.S. will take you to a map showing the number of trials in each state. Clicking on Minnesota will bring up a list of all clinical trials in Minnesota. Note that these will include trials other than AD trials.)