The epidemiology is promising, but the trial evidence is weak. Why pharmacological dementia risk reduction trials haven't lived up to expectations, and where do we go from here?

Ruth Peters, Hiroko H. Dodge, Sarah James, Gregory A. Jicha, Pierre Francois Meyer, Marcus Richards, A. David Smith, Hussein N. Yassine, Erin Abner, Atticus H. Hainsworth, Patrick G. Kehoe, Nigel Beckett, Craig S. Anderson, Kaarin J. Anstey

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

There is an urgent need for interventions that can prevent or delay cognitive decline and dementia. Decades of epidemiological research have identified potential pharmacological strategies for risk factor modification to prevent these serious conditions, but clinical trials have failed to confirm the potential efficacy for such interventions. Our multidisciplinary international group reviewed seven high-potential intervention strategies in an attempt to identify potential reasons for the mismatch between the observational and trial results. In considering our findings, we offer constructive recommendations for the next steps. Overall, we observed some differences in the observational evidence base for the seven strategies, but several common methodological themes that emerged. These themes included the appropriateness of trial populations and intervention strategies, including the timing of interventions and other aspects of trials methodology. To inform the design of future clinical trials, we provide recommendations for the next steps in finding strategies for effective dementia risk reduction.

Original languageEnglish
Pages (from-to)507-512
Number of pages6
JournalAlzheimer's and Dementia
Volume18
Issue number3
DOIs
StatePublished - Mar 2022

Bibliographical note

Publisher Copyright:
© 2021 the Alzheimer's Association.

Funding

Ruth Peters is funded by the Australian National Health and Medical Research Centre (NHMRC), Dementia Centre for Research Collaboration. Hiroko H. Dodge is supported by the NIH (R01AG051628, R01 AG056102, U2CAG054397, P30AG066518, P30 AG008017, P30AG024978, R01AG056712, R01AG0380651, R21AG062679, U2CAG057441, R01AG069782). Sarah James is funded by the U.K. Medical Research Council Gregory A. Jicha is supported by the NIH (R01 AG061111, UH3 NS100606, R01 AG054130, R01 AG061848, R01 AG054029, R01 AG063689, U19 AG010483, R56 AG060608, U24 AG057437, R01 AG053798, P30 AG028383, R01 HD064993, U19 AG024904, R01 AG057187, R01 NS116058, R01 NS116990) and receives contract grant support from AbbVie, Alltech, Biohaven, Eisai, Lilly, Novartis, and Suven. Pierre‐Francois Meyer reports no conflict of interest. Marcus Richards is a member of the steering committee for the Dementias Platform U.K. (DPUK) and receives funding from the U.K. Medical Research Centre (MRC). David Smith is a member of the scientific advisory board for Elysium Health and a Consultant for Aprofol. Hussein N. Yassine is a member of the steering committee of the National Institute on Aging Research and Education Core. He is supported by R21AG056518, R01AG055770, R01AG054434, R01AG067063 from the National Institute on Aging. Erin Abner reports no conflict of interest. Atticus H. Hainsworth: work in Dr. Hainsworth's laboratory is funded by grants from Alzheimer's Society (U.K.) and Alzheimer's Drug Discovery Foundation (Project Ref 20140901). Dr. Hainsworth has received honoraria from Eli Lilly and NIA and is a member of the Vascular Experimental Medicine group within DPUK. Patrick G. Kehoe received a research grant from NIHR‐EME to undertake a Phase II randomised controlled trial of losartan in mild to moderate Alzheimer's disease. Nigel Beckett reports no conflict of interest. Craig Anderson reports grant funding from the NHMRC, grants to his institution from Takeda China, and honoraria. Kaarin J. Anstey is a member of the Governance Committee of the Global Council on Brain Health, an advisor for the Staying Sharp platform for American Association of Retired Persons, and receives funding from NHMRC Fellowship:#1100579 NHMRC Centre of Research Excellence Grant #1102694 ARC CE170100005. This manuscript was facilitated by the Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment (ISTAART), through the Clinical Trials and Methodology professional interest area (PIA). The views and opinions expressed by authors in this publication represent those of the authors and do not necessarily reflect those of the PIA membership, ISTAART, or the Alzheimer's Association.

FundersFunder number
Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment
Australian National Health and Medical Research Centre
ISTAART
NIHR‐EME1102694 ARC CE170100005, 1100579
U.K. Medical Research Centre
National Institutes of Health (NIH)P30AG066518, R21AG062679, P30 AG008017, R01AG056712, R01AG069782, R01AG0380651, R01AG051628, P30AG024978, R01 AG056102, U2CAG054397, U2CAG057441
National Institute on Aging
Alzheimer's Association
Alzheimer's Drug Discovery Foundation20140901
Medical Research CouncilR01 AG061848, R01 NS116058, P30 AG028383, R01 NS116990, R21AG056518, R01 AG054130, U19 AG024904, U24 AG057437, UH3 NS100606, R01 AG057187, R01AG055770, U19 AG010483, R01 AG053798, R01 AG054029, R01AG054434, R56 AG060608, R01AG067063, R01 HD064993, R01 AG063689, R01 AG061111
Alzheimer's Society
National Health and Medical Research Council Clinical Trials Centre

    Keywords

    • Alzheimer's disease
    • clinical trials
    • dementia
    • epidemiology

    ASJC Scopus subject areas

    • Clinical Neurology
    • Geriatrics and Gerontology
    • Psychiatry and Mental health
    • Cellular and Molecular Neuroscience
    • Health Policy
    • Developmental Neuroscience
    • Epidemiology

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