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Recruiting NCT06529744

Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling

— Observational Dementia Alzheimer Disease Dementia With Lewy Bodies Vascular Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dementia, Alzheimer Disease, Dementia With Lewy Bodies, Vascular Dementia. Basic parameters: 30 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

To develop a model to predict disease progression in a large cohort of patients across a variety of neurodegenerative diseases, including Mild Cognitive Impairment (MCI) and dementia due to any neurodegenerative disease, including Alzheimer's Disease (AD), Lewy Body Disease (LBD), Vascular Disease (VaD) and Frontotemporal lobar degeneration (FTLD).

Detailed description

The goal of this study is to create a model to predict disease progression in patients with mild cognitive impairments and forms of dementia. To accomplish this, the current study will evaluate different tests including: brain imaging (MRI), body fluid samples (blood and cerebrospinal fluid), skin biopsy, cognitive ability, and behavioural questionnaires. The study team hopes that this information can be used to guide diagnosis and better predict disease progression in patients with mild cognitive impairment and and early dementia.

Primary outcome measures

  • Cognitive phenotype [Time frame: Baseline, 6-month follow-up, 1-year follow-up]
Secondary outcome measures (3)
  • Assessment of DNA methylation (DNAm) from bloodwork [Time frame: Baseline]
  • Neurodegenerative protein levels in biofluids and skin biopsy [Time frame: Baseline, 6-month follow-up, 1-year follow-up]
  • Structural and Functional Differences between neurodegenerative diseases via MRI of the brain [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Possible or probable diagnosis of MCI or early dementia
  • Age 30-95
  • Study partner who has some weekly contact with patient. Some of the neuropsychological assessment require collateral from close contacts to assess cognition and functioning. Since neurodegenerative diseases can be associated with reduced cognition, including reduced awareness of one's own impairments, participants will be assessed for their capacity to consent at all study visits.
  • Must, in the opinion of the site investigator, be able to complete most study procedures.

Exclusion criteria

  • Participants who are not able to complete the majority of assessments in the opinion of the PI are excluded from the study. Exclusion criteria are evaluated at the site investigator's discretion; if the site investigator believes that the participant's symptoms are due to causes other than neurodegeneration, despite the presence of an exclusionary condition, the investigator may overrule the exclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Canada · 4 centers
  • Baycrest — North York
  • Sunnybrook Health Sciences Centre — Toronto
  • Toronto Western Hospital, University Health Network — Toronto
  • Centre for Addiction and Mental Health — Toronto

Publications

  • Robinson JL, Lee EB, Xie SX, Rennert L, Suh E, Bredenberg C, Caswell C, Van Deerlin VM, Yan N, Yousef A, Hurtig HI, Siderowf A, Grossman M, McMillan CT, Miller B, Duda JE, Irwin DJ, Wolk D, Elman L, McCluskey L, Chen-Plotkin A, Weintraub D, Arnold SE, Brettschneider J, Lee VM, Trojanowski JQ. Neurodegenerative disease concomitant proteinopathies are prevalent, age-related and APOE4-associated. Bra PMID 29878075
  • Frost GR, Jonas LA, Li YM. Friend, Foe or Both? Immune Activity in Alzheimer's Disease. Front Aging Neurosci. 2019 Dec 10;11:337. doi: 10.3389/fnagi.2019.00337. eCollection 2019. PMID 31920620
  • Bergsma T, Rogaeva E. DNA Methylation Clocks and Their Predictive Capacity for Aging Phenotypes and Healthspan. Neurosci Insights. 2020 Jul 21;15:2633105520942221. doi: 10.1177/2633105520942221. eCollection 2020. PMID 32743556
  • Zhang M, Tartaglia MC, Moreno D, Sato C, McKeever P, Weichert A, Keith J, Robertson J, Zinman L, Rogaeva E. DNA methylation age-acceleration is associated with disease duration and age at onset in C9orf72 patients. Acta Neuropathol. 2017 Aug;134(2):271-279. doi: 10.1007/s00401-017-1713-y. Epub 2017 Apr 24. PMID 28439722
  • Zhang M, McKeever PM, Xi Z, Moreno D, Sato C, Bergsma T, McGoldrick P, Keith J, Robertson J, Zinman L, Rogaeva E. DNA methylation age acceleration is associated with ALS age of onset and survival. Acta Neuropathol. 2020 May;139(5):943-946. doi: 10.1007/s00401-020-02131-z. Epub 2020 Mar 7. No abstract available. PMID 32146547
  • Thijssen EH, La Joie R, Wolf A, Strom A, Wang P, Iaccarino L, Bourakova V, Cobigo Y, Heuer H, Spina S, VandeVrede L, Chai X, Proctor NK, Airey DC, Shcherbinin S, Duggan Evans C, Sims JR, Zetterberg H, Blennow K, Karydas AM, Teunissen CE, Kramer JH, Grinberg LT, Seeley WW, Rosen H, Boeve BF, Miller BL, Rabinovici GD, Dage JL, Rojas JC, Boxer AL; Advancing Research and Treatment for Frontotemporal L PMID 32123386
  • Janelidze S, Berron D, Smith R, Strandberg O, Proctor NK, Dage JL, Stomrud E, Palmqvist S, Mattsson-Carlgren N, Hansson O. Associations of Plasma Phospho-Tau217 Levels With Tau Positron Emission Tomography in Early Alzheimer Disease. JAMA Neurol. 2021 Feb 1;78(2):149-156. doi: 10.1001/jamaneurol.2020.4201. PMID 33165506
  • Ashton NJ, Pascoal TA, Karikari TK, Benedet AL, Lantero-Rodriguez J, Brinkmalm G, Snellman A, Scholl M, Troakes C, Hye A, Gauthier S, Vanmechelen E, Zetterberg H, Rosa-Neto P, Blennow K. Plasma p-tau231: a new biomarker for incipient Alzheimer's disease pathology. Acta Neuropathol. 2021 May;141(5):709-724. doi: 10.1007/s00401-021-02275-6. Epub 2021 Feb 14. PMID 33585983

Identifiers

NCT: NCT06529744 · 24-5283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗