New directions in clinical trials for frontotemporal lobar degeneration: methods and outcome measures
Open accessAbstract
Introduction: Frontotemporal lobar degeneration (FTLD) is the most common form of dementia for those under 60 years of age. Increasing numbers of therapeutics targeting FTLD syndromes are being developed. Methods: In March 2018, the Association for Frontotemporal Degeneration convened the Frontotemporal Degeneration Study Group meeting in Washington, DC, to discuss advances in the clinical science of FTLD. Results: Challenges exist for conducting clinical trials in FTLD. Two of the greatest challenges are (1) the heterogeneity of FTLD syndromes leading to difficulties in efficiently measuring treatment effects and (2) the rarity of FTLD disorders leading to recruitment challenges. Discussion: New personalized endpoints that are clinically meaningful to individuals and their families should be developed. Personalized approaches to analyzing MRI data, development of new fluid biomarkers and wearable technologies will help to improve the power to detect treatment effects in FTLD clinical trials and enable new, clinical trial designs, possibly leveraged from the experience of oncology trials. A computational visualization and analysis platform that can support novel analyses of combined clinical, genetic, imaging, biomarker data with other novel modalities will be critical to the success of these endeavors.
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The heterogeneity of the clinical presentation prevents the use of clinical or imaging indices as outcome measures in FTD treatment development.
“Such markers are very important for FTD treatment development, as the heterogeneity of the clinical presentation prevents the use of clinical or imaging indices as outcome measures.”
From New developments of biofluid‐based biomarkers for routine diagnosis and disease trajectories in frontotemporal dementia (2022) · cites this paper as [51]
While blood NfL has promise for measuring treatment effects in different neurodegenerative disorders, its utility as an endpoint measure in GRN carriers appears to be limited by the observed longitudinal fluctuations.
“While blood NfL has promise for measuring treatment effects in different neurodegenerative disorders, 51 , 92 , 111 , 112 its utility as an endpoint measure in GRN carriers appears to be limited by the observed longitudinal fluctuations.”
From New developments of biofluid‐based biomarkers for routine diagnosis and disease trajectories in frontotemporal dementia (2022) · cites this paper as [51]
Use of newly developed psychometric measures for characterizing all stages of symptoms in familial FTD research will facilitate the discovery and validation of early FTD biomarkers.
“Use of newly developed psychometric measures for characterizing all stages of symptoms (e.g., FTLD‐Clinical Dementia Rating, Multidomain Impairment Rating) in familial FTD research will facilitate the discovery and validation of early FTD biomarkers. 51 , 127”
From New developments of biofluid‐based biomarkers for routine diagnosis and disease trajectories in frontotemporal dementia (2022) · cites this paper as [51]
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Boeve, B. F., Boxer, A. L., Kumfor, F., Pijnenburg, Y., & Rohrer, J. D. (2022) · The Lancet Neurology · doi:10.1016/s1474-4422(21)00341-0 · Cited by 218 · see citing works
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Self-citationAdvances in the treatment and management of frontotemporal dementia
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Frontotemporal dementia. How to deal with its diagnostic complexity?
Antonioni, A., Raho, E. M., Granieri, E., & Koch, G. (2025) · Expert Review of Neurotherapeutics · doi:10.1080/14737175.2025.2461758 · Cited by 21 · see citing works
Pharmacotherapy for Frontotemporal Dementia
Khoury, R., Liu, Y., Sheheryar, Q., & Grossberg, G. T. (2021) · CNS Drugs · doi:10.1007/s40263-021-00813-0 · Cited by 20 · see citing works
Saloner, R., Staffaroni, A. M., Dammer, E. B., Johnson, E. C. B., Paolillo, E. W., Wise, A. B., Heuer, H. W., Forsberg, L. K., Lario‐Lago, A., Webb, J. D., et al. (2025) · Nature Aging · doi:10.1038/s43587-025-00878-2 · Cited by 18 · see citing works
Self-citationReyes‐Leiva, D., Dols‐Icardo, O., Sirisi, S., Cortés‐Vicente, E., Turón‐Sans, J., de Luna, N., Blesa, R., Belbin, O., Montal, V., Alcolea, D. A., et al. (2022) · Frontiers in Neurology · doi:10.3389/fneur.2021.750543 · Cited by 15 · see citing works
Identifying and Diagnosing TDP-43 Neurodegenerative Diseases in Psychiatry
Ducharme, S., Pijnenburg, Y. A. L., Rohrer, J. D., Huey, E. D., Finger, E. C., & Tatton, N. A. (2023) · American Journal of Geriatric Psychiatry · doi:10.1016/j.jagp.2023.08.017 · Cited by 16 · see citing works
Self-citationHok‐A‐Hin, Y. S., Hoozemans, J. J. M., Hu, W. T., Wouters, D., Howell, J. C., Rábano, A., van der Flier, W. M., Pijnenburg, Y. A. L., Teunissen, C. E., & del Campo, M. (2022) · Alzheimer s Research & Therapy · doi:10.1186/s13195-022-01039-y · Cited by 15 · see citing works
Whiteside, D. J., Street, D., Murley, A. G., Jones, P. S., Malpetti, M., Ghosh, B. C. P., Coyle-Gilchrist, I. T. S., Gerhard, A., Hu, M. T., Klein, J. C., et al. (2023) · Human Brain Mapping · doi:10.1002/hbm.26342 · Cited by 13 · see citing works
Rohrer, J. D., & Boxer, A. L. (2021) · Advances in experimental medicine and biology · doi:10.1007/978-3-030-51140-1_8 · Cited by 12 · see citing works
Self-citationMagnetic Resonance Imaging in Tauopathy Animal Models
Ni, R. (2022) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2021.791679 · Cited by 8 · see citing works
Twenty years of therapeutic development in tauopathy mouse models: a scoping review
Langness, V. F., Simmons, D. A., McHugh, T. L. M., Butler, R. R., Zhou, J., Liu, H., Yang, T., Ellerby, L., & Longo, F. M. (2025) · Alzheimer s & Dementia · doi:10.1002/alz.70578 · Cited by 9 · see citing works
Divergent FUS phosphorylation in primate and mouse cells following double-strand DNA damage
Johnson, M. A., Deng, Q., Taylor, G., McEachin, Z. T., Chan, A. W. S., Root, J. T., Bassell, G. J., & Kukar, T. L. (2020) · Neurobiology of Disease · doi:10.1016/j.nbd.2020.105085 · Cited by 7 · see citing works
Ortner, M., Goldhardt, O., Diehl‐Schmid, J., Yakushev, I. Y., Lanz, K., Hedderich, D. M., Manuilova, E., Simon, M., Weinberger, J.-P., & Grimmer, T. (2022) · The Journal of Prevention of Alzheimer s Disease · doi:10.14283/jpad.2022.27 · Cited by 9 · see citing works
A Clinicopathologic Study of Movement Disorders in Frontotemporal Lobar Degeneration
Pablo‐Fernández, E. D., González‐Herrero, B., Santacruz, D. M. C., Rossor, M. N., Schott, J. M., Lashley, T., Holton, J. L., Fox, N. C., Révész, T., Warren, J. D., et al. (2020) · Movement Disorders · doi:10.1002/mds.28356 · Cited by 8 · see citing works
Self-citationPhase 2 study of palmitoylethanolamide combined with luteoline in frontotemporal dementia patients
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Detection of emerging neurodegeneration using Bayesian linear mixed-effect modeling
Cobigo, Y., Goh, M. S., Wolf, A. A., Staffaroni, A. M., Kornak, J., Miller, B. L., Rabinovici, G. D., Seeley, W. W., Spina, S., Boxer, A. L., et al. (2022) · NeuroImage Clinical · doi:10.1016/j.nicl.2022.103144 · Cited by 7 · see citing works
Self-citationBoeve, B. F., & Rosen, H. J. (2021) · Advances in experimental medicine and biology · doi:10.1007/978-3-030-51140-1_6 · Cited by 7 · see citing works
Self-citationSaracino, D., & Ber, I. L. (2022) · Revue Neurologique · doi:10.1016/j.neurol.2022.03.007 · Cited by 6 · see citing works
del Campo, M., Pijnenburg, Y. A. L., Chen‐Plotkin, A. S., Irwin, D. J., Grossman, M., Twaalfhoven, H. A. M., Hu, W. T., Meeter, L. H. H., Swieten, J. C. V., Vermunt, L., et al. (2021) · Biomolecules · doi:10.3390/biom11101484 · Cited by 6 · see citing works
Self-citationHoney, M. I. J., Hok‐A‐Hin, Y. S., Thijssen, E. H., Cousins, K. A. Q., van der Weijden, B., Veld, L. I. ‘., Stoops, E., de Boer, S. C. M., Duits, F. H., Houwer, J. F. H. D., et al. (2026) · Nature Medicine · doi:10.1038/s41591-026-04341-6 · Cited by 6 · see citing works
Self-citationSemantic dementia: a complex and culturally influenced presentation
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Rodriguez‐Vieitez, E., Rydell, M. T., Ullgren, A., Montal, V., Illán‐Gala, I., Fortea, J., Jelić, V., Bouzigues, A., Russell, L. L., Foster, P. H., et al. (2025) · Molecular Psychiatry · doi:10.1038/s41380-025-03280-x · Cited by 3 · see citing works
Self-citationBagyinszky, E., & An, S. S. A. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26209960 · Cited by 3 · see citing works
Clinical Trial Development in Frontotemporal Lobar Degeneration
Ljubenkov, P. A., & Boxer, A. L. (2022) · Cambridge University Press eBooks · doi:10.1017/9781108975759.019 · Cited by 3 · see citing works
Self-citationRyan, B., Baker, A. O., Ilse, C., Brickell, K. L., Kersten, H. M., Williams, J. M., Addis, D. R., Tippett, L. J., & Curtis, M. A. (2022) · Journal of the Royal Society of New Zealand · doi:10.1080/03036758.2022.2101483 · Cited by 3 · see citing works
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Marth, L., Martínez-Murcia, F. J., Górriz, J. M., Denecke, J., Ewers, M., Prix, C., Stockbauer, A., Bernhardt, A. M., Wagemann, O., Wlasich, E., et al. (2026) · Neurology · doi:10.1212/wnl.0000000000214510 · Cited by 2 · see citing works
Clinical and neuropathological variability in the rare IVS10 + 14 tau mutation
Maxwell, S. P., Cash, M. K., Rockwood, K. J., Fisk, J. D., & Darvesh, S. (2021) · Neurobiology of Aging · doi:10.1016/j.neurobiolaging.2021.01.004 · Cited by 2 · see citing works
Self-citationSeltene Demenzerkrankungen: Frontotemporale Demenz
Diehl‐Schmid, J. (2023) · Fortschritte der Neurologie · Psychiatrie · doi:10.1055/a-2055-4496 · Cited by 2 · see citing works
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Clinicopathological features of primary tauopathies: a brain bank series
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Neuroprotection trial design in progressive supranuclear palsy: challenges and solutions
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Clinical dimensions along the progressive nonfluent variant primary progressive aphasia spectrumPreprint
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Seltene Demenzerkrankungen: Frontotemporale Demenz
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Frontotemporal lobar degeneration
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The Search for Answers: Causes, Risk Factors, and Current Research in Neurodegenerative Disorders
Kajrolkar, A. (2025) · Premier Journal of Neuroscience · doi:10.70389/pjn.100013
Treatment of Frontotemporal Dementias
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Hok‐A‐Hin, Y. S., Hoozemans, J. J. M., Hu, W. T., Wouters, D., Howell, J. C., Rábano, A., van der Flier, W. M., Pijnenburg, Y. A. L., Teunissen, C. E., & del Campo, M. (2022) · Figshare · doi:10.6084/m9.figshare.20374647
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Lessons from the Colombian kindred: rethinking Alzheimer's prevention
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Diagnosis and management of frontotemporal dementia: a narrative review
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Machine-learning MRI stratification of genetic frontotemporal dementia for clinical trial enrichmentPreprint
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Self-citationSupporting frontline staff in frontotemporal degeneration research
Dodge, S. G., Carter, D. J., Kamel, D., Lunde, A. M., Hlava, Q., Nelson, K. M., & Dacks, P. A. (2026) · Frontiers in Neurology · doi:10.3389/fneur.2026.1906002
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- Authors
- Boxer, A. L., Gold, M., Feldman, H., Boeve, B. F., Dickinson, S. L.-J., Fillit, H., Ho, C., Paul, R., Pearlman, R., Sutherland, M., Verma, A., Arneric, S. P., Alexander, B. M., Dickerson, B. C., Dorsey, E. R., Grossman, M., Huey, E. D., Irizarry, M. C., Marks, W. J., Masellis, M., McFarland, F., Niehoff, D., Onyike, C. U., Paganoni, S., Panzara, M. A., Rockwood, K., Rohrer, J. D., Rosen, H., Schuck, R. N., Soares, H. D., & Tatton, N.
- Affiliations
- University of California, San Francisco (US)
- AbbVie (United States) (US)
- University of California San Diego (US)
- Mayo Clinic (US)
- Association for Frontotemporal Degeneration (US)
- Alzheimer's Drug Discovery Foundation (US)
- Denali Therapeutics (United States) (US)
- Alector (United States) (US)
- Chan Zuckerberg Initiative (United States) (US)
- Harvard University (US)
- Massachusetts General Hospital (US)
- University of Rochester (US)
- University of Pennsylvania (US)
- Columbia University (US)
- Eli Lilly (United States) (US)
- Verily Life Sciences LLC (United States) (US)
- Sunnybrook Health Science Centre (CA)
- Johns Hopkins University (US)
- Wave Life Sciences (United States) (US)
- Dalhousie University (CA)
- National Hospital for Neurology and Neurosurgery (GB)
- United States Food and Drug Administration (US)
- Corresponding author
- Boxer, Adam L.
- ORCID
- Boxer, Adam L.
- Gold, Michael
- Feldman, Howard
- Boeve, Bradley F.
- Fillit, Howard
- Ho, Carole
- Paul, Robert
- Pearlman, Rodney
- Sutherland, Margaret
- Verma, Ajay
- Alexander, Brian M.
- Dickerson, Bradford C.
- Dorsey, Earl Ray
- Grossman, Murray
- Huey, Edward D.
- Irizarry, Michael C.
- Marks, William J.
- Masellis, Mario
- Onyike, Chiadi U.
- Paganoni, Sabrina
- Panzara, Michael A.
- Rockwood, Kenneth
- Rohrer, Jonathan D.
- Rosen, Howard
- Schuck, Robert N.
- Soares, Holly D.
- Tatton, Nadine
- Venue
- Alzheimer's & Dementia
- Publisher
- Wiley
- Published
- 2020-01
- Volume
- 16
- Issue
- 1
- Pages
- 131-143
- ISSN
- 1552-5260 (ISSN-L)
- 1552-5279
- PMC
- PMC6949386
- OpenAlex
- W2981318929
- Cited by
- 71
- References
- 131
- Citations by year
- 2026: 10 · 2025: 11 · 2024: 2 · 2023: 12 · 2022: 20 · 2021: 10 · 2020: 5 · 2019: 1
- FWCI
- 7.16
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Alzheimer s & Dementia (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- Association for Frontotemporal Degeneration
- National Institutes of Health (U54NS092089)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Neurology › Amyotrophic Lateral Sclerosis Research
- Keywords
- frontotemporal lobar degeneration, clinical trial design
- MeSH terms
- Atrophy, Clinical Trials as Topic, Congresses as Topic, Humans, Magnetic Resonance Imaging, Biomarkers, Frontotemporal Lobar Degeneration
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