AzTrials
AzTrials

DementiaCRND TorCANCT06529744

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

An observational study of Dementia and Alzheimer Disease, run by University Health Network, Toronto at 4 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 30 to 95 years
How many people
500 participants
Where
4 sitesCanada
Study dates
11 Nov 2023to Nov 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals who have been diagnosed with a mild cognitive impairment or early stage dementia that are between the ages of 30-95 can participate in the study as long as they have a study partner who can answer questionnaires at their 3 study visits and can complete a majority of assessments.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Claudia Clementi, HBSc contact

416-603-5914

claudia.clementi@uhn.ca

Canada4 sites, 4 recruiting

  • Baycrest

    North York, Ontario, M6A 2E1

    Aymin Mumtaz, 416-785-2500 ext. 6324, amumtaz@research.baycrest.org

    Morris Freedman, MD

    Not yet recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Ljubica Zotovic, 416-480-6100 ext. 3004, ljubica.zotovic@sunnybrook.ca

    Sandra E Black, MD

    Not yet recruiting

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario, M5T 2S8

    Claudia Clementi, 416-603-5914, claudia.clementi@uhn.ca

    Maria C Tartaglia, MD

    Recruiting

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H1

    Loreque Fearon, BASc, 416-535-8501 ext. 39589, Loreque.Fearon@camh.ca

    Tarek Rajji, MD

    Not yet recruiting

Other trials in Canada

About this study

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).

Read the 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.

Keywords
alzheimer's disease, dementia, dementia with lewy bodies, vascular dementia, frontotemporal dementia, mild cognitive impairment, corticobasal syndrome, progressive supranuclear palsy, parkinson's disease, primary progressive aphasia
Medical subject headings
Dementia, Alzheimer Disease, Lewy Body Disease, Dementia, Vascular, Frontotemporal Dementia, Cognitive Dysfunction, Corticobasal Degeneration, Supranuclear Palsy, Progressive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive phenotype

    Change in Toronto Cognitive Assessment (TorCA) scores out of 330, where lower scores indicate increasing cognitive impairments, and individual domains.

    Measured: Baseline, 6-month follow-up, 1-year follow-up

Secondary outcomes (3)

  1. Assessment of DNA methylation (DNAm) from bloodwork

    Biological age from DNA methylation (DNAm) collected via bloodwork compared to chronological age.

    Measured: Baseline

  2. Neurodegenerative protein levels in biofluids and skin biopsy

    Differences in protein levels between neurodegenerative diagnoses and predictive ability for change in TorCA

    Measured: Baseline, 6-month follow-up, 1-year follow-up

  3. Structural and Functional Differences between neurodegenerative diseases via MRI of the brain

    Brain volumes and white matter hyperintensity (WMH) load corresponding to Toronto Cognitive Assessment (TorCA) scores out of 330 where lower scores indicate increasing cognitive impairments.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start11 Nov 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06529744
Sponsor's protocol ID
24-5283
Acronym
CRND TorCA
Status last verified
Nov 2025
First submitted
29 Apr 2024
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be available to other researchers. Only anonymized responses to the cognitive assessment, clinical assessment, behavioural questionnaires and biofluid protein levels will be shared.

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. Brain. 2018 Jul 1;141(7):2181-2193. doi: 10.1093/brain/awy146.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 Lobar Degeneration (ARTFL) investigators. Diagnostic value of plasma phosphorylated tau181 in Alzheimer's disease and frontotemporal lobar degeneration. Nat Med. 2020 Mar;26(3):387-397. doi: 10.1038/s41591-020-0762-2. Epub 2020 Mar 2.

    PubMed 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.

    PubMed 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.

    PubMed 33585983

  • Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.

    PubMed 29653606

  • Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Feldman HH, Frisoni GB, Hampel H, Jagust WJ, Johnson KA, Knopman DS, Petersen RC, Scheltens P, Sperling RA, Dubois B. A/T/N: An unbiased descriptive classification scheme for Alzheimer disease biomarkers. Neurology. 2016 Aug 2;87(5):539-47. doi: 10.1212/WNL.0000000000002923. Epub 2016 Jul 1.

    PubMed 27371494

  • Amor S, Puentes F, Baker D, van der Valk P. Inflammation in neurodegenerative diseases. Immunology. 2010 Feb;129(2):154-69. doi: 10.1111/j.1365-2567.2009.03225.x.

    PubMed 20561356

  • Cuyvers E, Sleegers K. Genetic variations underlying Alzheimer's disease: evidence from genome-wide association studies and beyond. Lancet Neurol. 2016 Jul;15(8):857-868. doi: 10.1016/S1474-4422(16)00127-7.

    PubMed 27302364

  • Woollacott IOC, Nicholas JM, Heller C, Foiani MS, Moore KM, Russell LL, Paterson RW, Keshavan A, Schott JM, Warren JD, Heslegrave A, Zetterberg H, Rohrer JD. Cerebrospinal Fluid YKL-40 and Chitotriosidase Levels in Frontotemporal Dementia Vary by Clinical, Genetic and Pathological Subtype. Dement Geriatr Cogn Disord. 2020;49(1):56-76. doi: 10.1159/000506282. Epub 2020 Apr 28.

    PubMed 32344399

  • Sims R, Hill M, Williams J. The multiplex model of the genetics of Alzheimer's disease. Nat Neurosci. 2020 Mar;23(3):311-322. doi: 10.1038/s41593-020-0599-5. Epub 2020 Feb 28.

    PubMed 32112059

  • Leonenko G, Baker E, Stevenson-Hoare J, Sierksma A, Fiers M, Williams J, de Strooper B, Escott-Price V. Identifying individuals with high risk of Alzheimer's disease using polygenic risk scores. Nat Commun. 2021 Jul 23;12(1):4506. doi: 10.1038/s41467-021-24082-z.

    PubMed 34301930

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia and Alzheimer Disease, run by University Health Network, Toronto at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claudia Clementi, HBSc (416-603-5914, claudia.clementi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive phenotype (time frame: Baseline, 6-month follow-up, 1-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06529744, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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