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Research Priorities for Preventing and Treating Alzheimer’s Disease and Related Dementias

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Alzheimer’s Disease and Related Dementias (AD/ADRD) are a group of neurodegenerative disorders that cause devastating impacts to health, affecting over 6.5 million Americans. Despite recent advances in the understanding of these disorders, there remains significant need for progress to effectively prevent and treat AD/ADRD. An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will conduct a study to assess the current state of research on AD/ADRD and identify research priorities for treating and preventing AD/ADRD.

Description

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will conduct a study and recommend research priorities to advance the prevention and treatment of Alzheimer's Disease and Related Dementias (AD/ADRD).

In conducting its study, the committee will:

  • Examine and assess the current state of biomedical research aimed at preventing and effectively treating AD/ADRD, along the research and development pipeline from basic to translational to clinical research;
  • Assess the evidence on nonpharmacological interventions (e.g., lifestyle, cognitive training) aimed at preventing and treating AD/ADRD;
  • Identify key barriers to advancing AD/ADRD prevention and treatment (e.g., infrastructure challenges that impede large scale precision medicine approaches, inadequate functional measures and biomarkers for assessing response to treatment, lack of diversity in biobanks and clinical trials), and opportunities to address these key barriers and catalyze advances across the field;
  • Review and synthesize the most promising areas of research into preventing and treating AD/ADRD.

Building on its review of past AD/ADRD strategic planning and related activities, existing literature and analyses, and other expert and public input, the committee will develop a report with its findings, conclusions, and recommendations on research priorities for preventing and treating AD/ADRD, including identifying specific near- and medium-term scientific questions (i.e., in a 3-to-10-year period) that may be addressed through National Institutes of Health (NIH) funding. The report will also include strategies for addressing major barriers to progress on these scientific questions.

The committee's study will include dementia caused by Alzheimer's disease as well as related conditions such as frontotemporal disorders, Lewy body dementia, vascular contributions to cognitive impairment/dementia, and multiple etiology dementias; dementias with a clear etiology (e.g., incident stroke, AIDS, traumatic brain injury) are outside the scope of this study. Dementia care and caregiving research, including care coordination, is outside the scope of this study.

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Conflict of Interest Disclosure

Disclosure of Unavoidable Conflicts of Interest Statement: Rhoda Au
The conflict of interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

Rhoda Au has a conflict of interest in relation to service on the Committee on Research Priorities for Preventing and Treating Alzheimer’s Disease and Related Dementias because of her compensated membership on the scientific advisory boards of Signant Health, Biogen, and Novo Nordisk.

The National Academies has concluded that in order for the committee to accomplish the tasks for which it was established, its membership must include at least one person who has current experience and broad expertise in the development of digital indicators (referred to as digital biomarkers) of brain health, AD/ADRD disease risk, and treatment response using digital health technologies and their translation to the private sector for AD/ADRD clinical research and diagnostic development. As described in her biographical summary, Dr. Au has extensive experience working with leading pharmaceutical and biotechnology companies working on the development of digital biomarkers as well as on the application of digital tools in clinical research settings. This research has the potential to streamline the collection and analysis of previously inaccessible physiological, environmental, and behavioral data from individuals over time and support future advances in AD/ADRD prevention and treatment research.

The National Academies has determined that the experience and expertise of Dr. Au is needed for the committee to accomplish the task for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.

The National Academies believes that Dr. Au can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.

Disclosure of Unavoidable Conflicts of Interest Statement: Rita Balice-Gordon
The conflict of interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

Rita Balice-Gordon has a conflict of interest in relation to service on the Committee on Research Priorities for Preventing and Treating Alzheimer’s Disease and Related Dementias because she is CEO of Muna Therapeutics, which focuses on disease modifying therapies for neurodegenerative diseases, including Alzheimer’s disease.

The National Academies has concluded that in order for the committee to accomplish the tasks for which it was established, its membership must include at least one person who has relevant current expertise in private sector drug development for AD/ADRD and experience in the effective translation of NIH-funded research to the private sector to bring novel therapeutics to market. As described in her biographical summary, as CEO of Muna Therapeutics and in her past leadership roles at Sanofi and Pfizer, Dr. Balice-Gordon has extensive experience in private-sector drug development for AD/ADRD.

The National Academies has determined that the experience and expertise of Dr. Balice-Gordon is needed for the committee to accomplish the task for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.

The National Academies believes that Dr. Balice-Gordon can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.

Disclosure of Unavoidable Conflicts of Interest Statement: Jeffrey Dage
The conflict of interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual’s actual behavior or character or ability to act objectively despite the conflicting interest. Jeffrey Dage has a conflict of interest in relation to the provision of advisory services to companies developing novel treatments for AD/ADRD, including ALZPath, Genotix Biotechnologies, and Prevail Therapeutics. Additionally, he is a consultant for and holds stock in Monument Biosciences and holds stock in Eli Lilly and Company.

The National Academies has concluded that for the committee to accomplish the tasks for which it was established, its membership must include at least one person who has current experience and deep expertise in the development and validation of fluid biomarkers for AD/ADRD, as well as expertise in translating biomarker research into tools for use in clinical and research settings. As described in his biographical summary, Dr. Dage has extensive experience in fluid biomarker development, validation, and application, which has the potential to accelerate future research across the AD/ADRD R&D pipeline and the development of novel treatments for neurodegenerative diseases.

The National Academies has determined that the experience and expertise of Dr. Dage is needed for the committee to accomplish the task for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.

The National Academies believes that Dr. Dage can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.

Disclosure of Unavoidable Conflicts of Interest Statement: Reisa Sperling
The conflict of interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual’s actual behavior or character or ability to act objectively despite the conflicting interest.

Reisa Sperling has a conflict of interest in relation to service on the Committee on Research Priorities for Preventing and Treating Alzheimer’s Disease and Related Dementias because she is a paid consultant to the following companies involved in drug development for the prevention and treatment of AD/ADRD including: AC Immune, Alector, Acumen, Bristol-Myers Squib, Genentech, Janssen, Neuraly, Oligomerix, Prothena, Renew, Vaxxinity, Merck, and Biohaven.

The National Academies has concluded that in order for the committee to accomplish the tasks for which it was established, its membership must include at least one person who has relevant current experience and expertise in the development and management of a large NIH-supported clinical trial consortium for Alzheimer’s disease and related dementias (AD/ADRD) and the use of such infrastructure to support innovative trial designs. As described in her biographical summary, Dr. Sperling serves on the leadership team for the Alzheimer’s Clinical Trials Consortium and has extensive experience working with companies to design and carry out innovative clinical trials for AD/ADRD to advance the development of potential treatments. The National Academies has determined that the experience and expertise of Dr. Sperling is needed for the committee to accomplish the task for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.

The National Academies believes that Dr. Sperling can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.

Committee Membership Roster Comments

10/1/23 - Dr. Chi Udeh-Momoh was added as a member of the committee.
11/1/23 - Minor edits made to the bios of Patricia Powell, Rhoda Au, Maria Glymour, Hector Gonzalez, Rita Doreen Monks, Kenneth Ramos, Reisa Sperling, Chi Udeh-Momoh, Li-San Wang, and Julie Zissimopoulos.
11/8/23 - Dr. Kenneth Langa was added as a member of the committee.
12/28/23 - Henrik Zetterberg resigned from the committee.
1/19/24 - Minor edits made to the bios of Pamela Lein and Reisa Sperling
2/23/24 - Dr. Jeffrey Dage was added as a member of the committee.
3/13/24 - Clyde Yancy resigned from the committee.
5/30 - Minor edits made to the bios of Nilüfer Ertekin-Taner, Resia Sperling, and Jeffrey Dage.

Sponsors

Department of Health and Human Services

Staff

Autumn Downey

Lead

Olivia Yost

Lead

Molly Checksfield Dorries

Lydia Teferra

Ashley Bologna

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