Alzheimer DiseasePLASMARNCT06246019
The Clinical Impact of the Novel Alzheimer's Blood-based Biomarkers
An observational study of Alzheimer Disease and Cognitive Impairment, run by Hospital del Mar Research Institute (IMIM) at 1 site in Spain.
Trial summary
The goal of this observational study is to determine whether the early adoption of blood-based biomarkers for Alzheimer's disease is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in patients presenting with cognitive complaints… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment, Dementia
- What is being tested?
- Early adoption of blood-based biomarkers for Alzheimer's disease
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2024to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PLASMAR is prospective, unicentric, unblinded and randomized controlled study with blinded outcome ascertainment. Two hundred new patients will be consecutively recruited. All consecutive new patients who are visited for the first time to the outpatients' Memory Clinic at the Neurology Service (Hospital del Mar, Barcelona, Spain) will be considered for the study. Each patient will name a study partner to participate in this study, who will be considered for the study as well. In case the patient is diagnosed with dementia, a caregiver will be considered.
Who may be able to join
- Subjects ≥18 and ≤85 years old of any sex, gender, race or ethnicity.
- Individuals interested in participating in the study who understand the procedures that will be performed.
- The patient must have a complaint (reported by the patient or by a study partner/caregiver) of cognitive or behavioral impairment.
- The patient must satisfy the clinical diagnostic criteria for subjective cognitive decline, mild cognitive impairment, or mild dementia (defined as a Global deterioration scale score equal to 4), and a neurodegenerative disease such as AD is considered in the differential diagnosis.
- Agreement to undergo all the study procedures, complete all clinical visits according to protocol and capacity to give informed consent.
- The patient has undergone (maximum 12 months ago) or will undergo a dementia blood workup and MRI and/or CT scan before V1.
- In dementia patients, a study partner must be available for the duration of the protocol.
Who cannot join
- Any significant systemic illness or unstable medical condition that could make it difficult to comply with the protocol.
- Medical contraindications for any of the study procedures.
- Available AD's cerebrospinal fluid biomarkers levels or amyloid-PET at screening.
- The patient comes to the Memory Unit for reasons other than cognitive or behavioral impairment.
- Patients in which an etiological diagnosis is already made.
- The patient is currently participating or has participated in a clinical trial with an investigational pharmaceutical product.
- Women who are pregnant, planning to become pregnant, or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Impact of the Novel Alzheimer's Blood-based Biomarkers: the PLASMAR Study
The goal of this observational study is to determine whether the early adoption of blood-based biomarkers for Alzheimer's disease is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in patients presenting with cognitive complaints in a Cognitive Disorders Unit from a public hospital.
The main questions it aims to answer are:
Read more
- Does the early adoption of blood-based biomarkers in clinical practice enable an earlier etiologic diagnosis with high confidence compared to the late adoption of blood-based biomarkers in the patients with cognitive complaints that are admitted in a Cognitive Disorders Unit?
- Is the early adoption of blood-based biomarkers in clinical practice associated with changes in clinical management compared to their late adoption?
- Is the early adoption of blood-based biomarkers in clinical practice associated with a lower emotional impact in the patients and their study partners/caregivers compared to their late adoption?
- Are blood-based biomarkers better tolerated than other tests and preferred by patients for the diagnostic work-up?
- Does blood-based biomarkers have an impact in the cost of the diagnostic workup and clinical management of the patients that are admitted in a Cognitive Disorders Unit?
Participants will be asked to:
- Perform a blood extraction for blood-based biomarkers analysis at the beginning of the study.
- Complete specific scales in each visit.
Researchers will compare the group in which blood biomarkers are delivered at 3 months with the group in which they are delivered at 9 months to assess whether early adoption of blood-based biomarkers is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in a specialized memory unit.
Read the detailed description
Blood-based biomarkers that accurately detect Alzheimer's disease (AD) and neurodegeneration now offer a realistic, cost-effective and non-invasive assessment that will aid the diagnostic process in patients presenting with cognitive clinical manifestations. Plasma measures of Amyloid-β (Aβ) 42/40, phosphorylated tau (p-tau) 181, p-tau217, p-tau231 and Glial fibrillary acidic protein (GFAP) have shown high diagnostic accuracy to detect AD, while plasma Neurofilament light chain (NfL) indicates neuronal injury. Despite these promising results, there is still no clear real-word evidence of their clinical applications. Here, the PLASMAR project aims to determine whether blood-based biomarkers have an impact on the clinical management of patients presenting with cognitive complaints in a Cognitive Disorders Unit from a public hospital, which provides care to a heterogeneous population. The project is divided into two specific objectives. First, the investigators will determine, in a research cohort, which blood biomarker or biomarkers' combination have the highest accuracy to detect AD. Second, a prospective clinical cohort of consecutive patients coming to the memory unit will be recruited. The investigators will assess whether early adoption of blood-based biomarkers is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in a specialized memory unit. Answering the question of whether blood-based biomarkers have a clinical impact in the real-world scenario of a memory unit, the PLASMAR project is crucial for the healthcare system and can guide the developing of guidelines and protocols on the use of blood-based biomarkers.
- Conditions
- Alzheimer Disease, Cognitive Impairment, Dementia, Neurodegenerative Diseases, Frontotemporal Dementia, Lewy Body Disease
- Being tested
- Early adoption of blood-based biomarkers for Alzheimer's disease
- Keywords
- Blood-biomarkers, Alzheimer Disease, Diagnosis, Dementia, Cognitive impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Neurodegenerative Diseases, Frontotemporal Dementia, Lewy Body Disease, Dementia, Vascular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early adoption of blood-based biomarkers for Alzheimer's diseaseDiagnostic test
A blood test will be performed to obtain plasma measures of Amyloid-β (Aβ) 42/40, phosphorylated tau (p-tau) 181, p-tau217, p-tau231 and Glial fibrillary acidic protein (GFAP) and Neurofilament light chain (NfL) and results will be disclosure to the early and late arms at different time points.
| Study group | Role | What they receive |
|---|---|---|
| Early Blood-based biomarkers Arm | The results of the blood-based biomarkers will be communicated to the managing neurologist at visit 1 (at 3 months from baseline visit). Receives: Diagnostic Test: Early adoption of blood-based biomarkers for Alzheimer's disease | |
| Late Blood-based biomarkers Arm | The results of the blood-based biomarkers will be communicated to the managing neurologist at visit 2 (at 9 months from baseline visit). Receives: Diagnostic Test: Early adoption of blood-based biomarkers for Alzheimer's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiological diagnosis
The proportion of patients for whom an etiologic diagnosis is reached with very high confidence (≥90%) in each group at 3 and 9 months.
Measured: 9 months
Suspicion of neurodegenerative disease
The proportion of patients for whom a suspicion of neurodegenerative disease is reached as etiology with very high confidence (≥90%) in each group at 3 and 9 months.
Measured: 9 months
Secondary outcomes (5)
Number of tests for etiological diagnosis
The number of tests necessary to reach an etiological diagnosis with very high confidence (≥90%) in each group at 3 and 9 months.
Measured: 9 months
Number of tests for a suspicion of neurodegenerative disease
The number of tests to reach a suspicion of neurodegenerative disease as etiology with very high confidence (≥90%) in each group at 3 and 9 months.
Measured: 9 months
Neurologist diagnoses over time
Changes in the neurologist's etiologic diagnosis in each group during the time of the study.
Measured: 9 months
Neurologist confidence in the etiological diagnosis, which is is collected through the PLASMAR questionnaire at each visit.
Changes in the neurologist's estimate of the likelihood that the patient's symptoms are due to AD in each group during the time of the study.
Measured: 9 months
Neurologist confidence in the suspicion of neurodegenerative disease, which is is collected through the PLASMAR questionnaire at each visit.
Changes in the neurologist's estimate of the likelihood that the patient's symptoms are due to a neurodegenerative disease as etiology in each group during the time of the study.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start7 Feb 2024
- Primary completionMay 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Suarez-Calvet, Hospital del Mar Research Institute (IMIM)
- Investigators
- Marc Suárez-Calvet, MD PhD, Principal investigator, Hospital del Mar Research Insititute (IMIM)Albert Puig-Pijoan, MD, Principal investigator, Hospital del Mar Research Insititute (IMIM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246019
- Sponsor's protocol ID
- 15225
- Acronym
- PLASMAR
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Altomare D, Barkhof F, Caprioglio C, Collij LE, Scheltens P, Lopes Alves I, Bouwman F, Berkhof J, van Maurik IS, Garibotto V, Moro C, Delrieu J, Payoux P, Saint-Aubert L, Hitzel A, Molinuevo JL, Grau-Rivera O, Gispert JD, Drzezga A, Jessen F, Zeyen P, Nordberg A, Savitcheva I, Jelic V, Walker Z, Edison P, Demonet JF, Gismondi R, Farrar G, Stephens AW, Frisoni GB; Amyloid Imaging to Prevent Alzheimer's Disease (AMYPAD) Consortium. Clinical Effect of Early vs Late Amyloid Positron Emission Tomography in Memory Clinic Patients: The AMYPAD-DPMS Randomized Clinical Trial. JAMA Neurol. 2023 Jun 1;80(6):548-557. doi: 10.1001/jamaneurol.2023.0997.
PubMed 37155177Grothe MJ, Moscoso A, Ashton NJ, Karikari TK, Lantero-Rodriguez J, Snellman A, Zetterberg H, Blennow K, Scholl M; Alzheimer's Disease Neuroimaging Initiative. Associations of Fully Automated CSF and Novel Plasma Biomarkers With Alzheimer Disease Neuropathology at Autopsy. Neurology. 2021 Sep 20;97(12):e1229-e1242. doi: 10.1212/WNL.0000000000012513.
PubMed 34266917Janelidze S, Mattsson N, Palmqvist S, Smith R, Beach TG, Serrano GE, Chai X, Proctor NK, Eichenlaub U, Zetterberg H, Blennow K, Reiman EM, Stomrud E, Dage JL, Hansson O. Plasma P-tau181 in Alzheimer's disease: relationship to other biomarkers, differential diagnosis, neuropathology and longitudinal progression to Alzheimer's dementia. Nat Med. 2020 Mar;26(3):379-386. doi: 10.1038/s41591-020-0755-1. Epub 2020 Mar 2.
PubMed 32123385Karikari TK, Pascoal TA, Ashton NJ, Janelidze S, Benedet AL, Rodriguez JL, Chamoun M, Savard M, Kang MS, Therriault J, Scholl M, Massarweh G, Soucy JP, Hoglund K, Brinkmalm G, Mattsson N, Palmqvist S, Gauthier S, Stomrud E, Zetterberg H, Hansson O, Rosa-Neto P, Blennow K. Blood phosphorylated tau 181 as a biomarker for Alzheimer's disease: a diagnostic performance and prediction modelling study using data from four prospective cohorts. Lancet Neurol. 2020 May;19(5):422-433. doi: 10.1016/S1474-4422(20)30071-5.
PubMed 32333900Simren J, Andreasson U, Gobom J, Suarez Calvet M, Borroni B, Gillberg C, Nyberg L, Ghidoni R, Fernell E, Johnson M, Depypere H, Hansson C, Jonsdottir IH, Zetterberg H, Blennow K. Establishment of reference values for plasma neurofilament light based on healthy individuals aged 5-90 years. Brain Commun. 2022 Jul 4;4(4):fcac174. doi: 10.1093/braincomms/fcac174. eCollection 2022.
PubMed 35865350Suarez-Calvet M, Karikari TK, Ashton NJ, Lantero Rodriguez J, Mila-Aloma M, Gispert JD, Salvado G, Minguillon C, Fauria K, Shekari M, Grau-Rivera O, Arenaza-Urquijo EM, Sala-Vila A, Sanchez-Benavides G, Gonzalez-de-Echavarri JM, Kollmorgen G, Stoops E, Vanmechelen E, Zetterberg H, Blennow K, Molinuevo JL; ALFA Study. Novel tau biomarkers phosphorylated at T181, T217 or T231 rise in the initial stages of the preclinical Alzheimer's continuum when only subtle changes in Abeta pathology are detected. EMBO Mol Med. 2020 Dec 7;12(12):e12921. doi: 10.15252/emmm.202012921. Epub 2020 Nov 10.
PubMed 33169916Thijssen EH, La Joie R, Strom A, Fonseca C, Iaccarino L, Wolf A, Spina S, Allen IE, Cobigo Y, Heuer H, VandeVrede L, Proctor NK, Lago AL, Baker S, Sivasankaran R, Kieloch A, Kinhikar A, Yu L, Valentin MA, Jeromin A, Zetterberg H, Hansson O, Mattsson-Carlgren N, Graham D, Blennow K, Kramer JH, Grinberg LT, Seeley WW, Rosen H, Boeve BF, Miller BL, Teunissen CE, Rabinovici GD, Rojas JC, Dage JL, Boxer AL; Advancing Research and Treatment for Frontotemporal Lobar Degeneration investigators. Plasma phosphorylated tau 217 and phosphorylated tau 181 as biomarkers in Alzheimer's disease and frontotemporal lobar degeneration: a retrospective diagnostic performance study. Lancet Neurol. 2021 Sep;20(9):739-752. doi: 10.1016/S1474-4422(21)00214-3.
PubMed 34418401Estragues-Gazquez I, Contador J, Martinez LD, Fernandez-Lebrero A, Garcia-Escobar G, Navalpotro-Gomez I, Grau-Rivera O, Iaccarino G, Manero-Borras RM, Ortiz-Romero P, Hernandez-Villamizar F, Torres-Torronteras J, de Diego-Osaba M, Blasco-Fornies H, Jimenez-Moyano E, Hernandez JJ, Padros A, Del Campo M, Puig-Pijoan A, Suarez-Calvet M. Earlier Disclosure of Blood-Based Biomarkers, Diagnostic Certainty, and Clinical Management: A Randomized Clinical Trial. JAMA Neurol. 2026 Oct 5:e263497. doi: 10.1001/jamaneurol.2026.3497. Online ahead of print.
PubMed 42832237
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Impact of the Novel Alzheimer's Blood-based Biomarkers: the PLASMAR Study
- ClinicalTrials.gov ID
- NCT06246019
- Acronym / sponsor ID
- PLASMAR / 15225
- Conditions
- Alzheimer Disease, Cognitive Impairment, Dementia, Neurodegenerative Diseases, Frontotemporal Dementia, Lewy Body Disease
- Keywords
- Blood-biomarkers, Alzheimer Disease, Diagnosis, Dementia, Cognitive impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)University, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to determine whether the early adoption of blood-based biomarkers for Alzheimer's disease is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in patients presenting with cognitive complaints in a Cognitive Disorders Unit from a public hospital.
The main questions it aims to answer are:
- Does the early adoption of blood-based biomarkers in clinical practice enable an earlier etiologic diagnosis with high confidence compared to the late adoption of blood-based biomarkers in the patients with cognitive complaints that are admitted in a Cognitive Disorders Unit?
- Is the early adoption of blood-based biomarkers in clinical practice associated with changes in clinical management compared to their late adoption?
- Is the early adoption of blood-based biomarkers in clinical practice associated with a lower emotional impact in the patients and their study partners/caregivers compared to their late adoption?
- Are blood-based biomarkers better tolerated than other tests and preferred by patients for the diagnostic work-up?
- Does blood-based biomarkers have an impact in the cost of the diagnostic workup and clinical management of the patients that are admitted in a Cognitive Disorders Unit?
Participants will be asked to:
- Perform a blood extraction for blood-based biomarkers analysis at the beginning of the study.
- Complete specific scales in each visit.
Researchers will compare the group in which blood biomarkers are delivered at 3 months with the group in which they are delivered at 9 months to assess whether early adoption of blood-based biomarkers is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in a specialized memory unit.
Detailed description
Blood-based biomarkers that accurately detect Alzheimer's disease (AD) and neurodegeneration now offer a realistic, cost-effective and non-invasive assessment that will aid the diagnostic process in patients presenting with cognitive clinical manifestations. Plasma measures of Amyloid-β (Aβ) 42/40, phosphorylated tau (p-tau) 181, p-tau217, p-tau231 and Glial fibrillary acidic protein (GFAP) have shown high diagnostic accuracy to detect AD, while plasma Neurofilament light chain (NfL) indicates neuronal injury. Despite these promising results, there is still no clear real-word evidence of their clinical applications. Here, the PLASMAR project aims to determine whether blood-based biomarkers have an impact on the clinical management of patients presenting with cognitive complaints in a Cognitive Disorders Unit from a public hospital, which provides care to a heterogeneous population. The project is divided into two specific objectives. First, the investigators will determine, in a research cohort, which blood biomarker or biomarkers' combination have the highest accuracy to detect AD. Second, a prospective clinical cohort of consecutive patients coming to the memory unit will be recruited. The investigators will assess whether early adoption of blood-based biomarkers is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in a specialized memory unit. Answering the question of whether blood-based biomarkers have a clinical impact in the real-world scenario of a memory unit, the PLASMAR project is crucial for the healthcare system and can guide the developing of guidelines and protocols on the use of blood-based biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Blood-based biomarkers Arm | – | Diagnostic Test: Early adoption of blood-based biomarkers for Alzheimer's diseaseThe results of the blood-based biomarkers will be communicated to the managing neurologist at visit 1 (at 3 months from baseline visit). |
| Late Blood-based biomarkers Arm | – | Diagnostic Test: Early adoption of blood-based biomarkers for Alzheimer's diseaseThe results of the blood-based biomarkers will be communicated to the managing neurologist at visit 2 (at 9 months from baseline visit). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PLASMAR is prospective, unicentric, unblinded and randomized controlled study with blinded outcome ascertainment. Two hundred new patients will be consecutively recruited. All consecutive new patients who are visited for the first time to the outpatients' Memory Clinic at the Neurology Service (Hospital del Mar, Barcelona, Spain) will be considered for the study. Each patient will name a study partner to participate in this study, who will be considered for the study as well. In case the patient is diagnosed with dementia, a caregiver will be considered.
Key inclusion criteria (7 listed)
- Subjects ≥18 and ≤85 years old of any sex, gender, race or ethnicity.
- Individuals interested in participating in the study who understand the procedures that will be performed.
- The patient must have a complaint (reported by the patient or by a study partner/caregiver) of cognitive or behavioral impairment.
- The patient must satisfy the clinical diagnostic criteria for subjective cognitive decline, mild cognitive impairment, or mild dementia (defined as a Global deterioration scale score equal to 4), and a neurodegenerative disease such as AD is considered in the differential diagnosis.
- Agreement to undergo all the study procedures, complete all clinical visits according to protocol and capacity to give informed consent.
Key exclusion criteria (7 listed)
- Any significant systemic illness or unstable medical condition that could make it difficult to comply with the protocol.
- Medical contraindications for any of the study procedures.
- Available AD's cerebrospinal fluid biomarkers levels or amyloid-PET at screening.
- The patient comes to the Memory Unit for reasons other than cognitive or behavioral impairment.
- Patients in which an etiological diagnosis is already made.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early adoption of blood-based biomarkers for Alzheimer's diseaseA blood test will be performed to obtain plasma measures of Amyloid-β (Aβ) 42/40, phosphorylated tau (p-tau) 181, p-tau217, p-tau231 and Glial fibrillary acidic protein (GFAP) and Neurofilament light chain (NfL) and results will be disclosure to the early and late arms at different time points. | Diagnostic test | Early Blood-based biomarkers Arm, Late Blood-based biomarkers Arm |
Primary outcome
Etiological diagnosis
Time frame: 9 months
The proportion of patients for whom an etiologic diagnosis is reached with very high confidence (≥90%) in each group at 3 and 9 months.
Suspicion of neurodegenerative disease
Time frame: 9 months
The proportion of patients for whom a suspicion of neurodegenerative disease is reached as etiology with very high confidence (≥90%) in each group at 3 and 9 months.
5 secondary outcomes
Number of tests for etiological diagnosis
Time frame: 9 months
Number of tests for a suspicion of neurodegenerative disease
Time frame: 9 months
Neurologist diagnoses over time
Time frame: 9 months
Neurologist confidence in the etiological diagnosis, which is is collected through the PLASMAR questionnaire at each visit.
Time frame: 9 months
Neurologist confidence in the suspicion of neurodegenerative disease, which is is collected through the PLASMAR questionnaire at each visit.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 37155177Altomare D, Barkhof F, Caprioglio C, Collij LE, Scheltens P, Lopes Alves I, Bouwman F, Berkhof J, van Maurik IS, Garibotto V, Moro C, Delrieu J, Payoux P, Saint-Aubert L, Hitzel A, Molinuevo JL, Grau-Rivera O, Gispert JD, Drzezga A, Jessen F, Zeyen P, Nordberg A, Savitcheva I, Jelic V, Walker Z, Edison P, Demonet JF, Gismondi R, Farrar G, Stephens AW, Frisoni GB; Amyloid Imaging to Prevent Alzheimer's Disease (AMYPAD) Consortium. Clinical Effect of Early vs Late Amyloid Positron Emission Tomography in Memory Clinic Patients: The AMYPAD-DPMS Randomized Clinical Trial. JAMA Neurol. 2023 Jun 1;80(6):548-557. doi: 10.1001/jamaneurol.2023.0997.
- Background: PubMed 34266917Grothe MJ, Moscoso A, Ashton NJ, Karikari TK, Lantero-Rodriguez J, Snellman A, Zetterberg H, Blennow K, Scholl M; Alzheimer's Disease Neuroimaging Initiative. Associations of Fully Automated CSF and Novel Plasma Biomarkers With Alzheimer Disease Neuropathology at Autopsy. Neurology. 2021 Sep 20;97(12):e1229-e1242. doi: 10.1212/WNL.0000000000012513.
- Background: PubMed 32123385Janelidze S, Mattsson N, Palmqvist S, Smith R, Beach TG, Serrano GE, Chai X, Proctor NK, Eichenlaub U, Zetterberg H, Blennow K, Reiman EM, Stomrud E, Dage JL, Hansson O. Plasma P-tau181 in Alzheimer's disease: relationship to other biomarkers, differential diagnosis, neuropathology and longitudinal progression to Alzheimer's dementia. Nat Med. 2020 Mar;26(3):379-386. doi: 10.1038/s41591-020-0755-1. Epub 2020 Mar 2.
- Background: PubMed 32333900Karikari TK, Pascoal TA, Ashton NJ, Janelidze S, Benedet AL, Rodriguez JL, Chamoun M, Savard M, Kang MS, Therriault J, Scholl M, Massarweh G, Soucy JP, Hoglund K, Brinkmalm G, Mattsson N, Palmqvist S, Gauthier S, Stomrud E, Zetterberg H, Hansson O, Rosa-Neto P, Blennow K. Blood phosphorylated tau 181 as a biomarker for Alzheimer's disease: a diagnostic performance and prediction modelling study using data from four prospective cohorts. Lancet Neurol. 2020 May;19(5):422-433. doi: 10.1016/S1474-4422(20)30071-5.
- Background: PubMed 35865350Simren J, Andreasson U, Gobom J, Suarez Calvet M, Borroni B, Gillberg C, Nyberg L, Ghidoni R, Fernell E, Johnson M, Depypere H, Hansson C, Jonsdottir IH, Zetterberg H, Blennow K. Establishment of reference values for plasma neurofilament light based on healthy individuals aged 5-90 years. Brain Commun. 2022 Jul 4;4(4):fcac174. doi: 10.1093/braincomms/fcac174. eCollection 2022.
- Background: PubMed 33169916Suarez-Calvet M, Karikari TK, Ashton NJ, Lantero Rodriguez J, Mila-Aloma M, Gispert JD, Salvado G, Minguillon C, Fauria K, Shekari M, Grau-Rivera O, Arenaza-Urquijo EM, Sala-Vila A, Sanchez-Benavides G, Gonzalez-de-Echavarri JM, Kollmorgen G, Stoops E, Vanmechelen E, Zetterberg H, Blennow K, Molinuevo JL; ALFA Study. Novel tau biomarkers phosphorylated at T181, T217 or T231 rise in the initial stages of the preclinical Alzheimer's continuum when only subtle changes in Abeta pathology are detected. EMBO Mol Med. 2020 Dec 7;12(12):e12921. doi: 10.15252/emmm.202012921. Epub 2020 Nov 10.
- Background: PubMed 34418401Thijssen EH, La Joie R, Strom A, Fonseca C, Iaccarino L, Wolf A, Spina S, Allen IE, Cobigo Y, Heuer H, VandeVrede L, Proctor NK, Lago AL, Baker S, Sivasankaran R, Kieloch A, Kinhikar A, Yu L, Valentin MA, Jeromin A, Zetterberg H, Hansson O, Mattsson-Carlgren N, Graham D, Blennow K, Kramer JH, Grinberg LT, Seeley WW, Rosen H, Boeve BF, Miller BL, Teunissen CE, Rabinovici GD, Rojas JC, Dage JL, Boxer AL; Advancing Research and Treatment for Frontotemporal Lobar Degeneration investigators. Plasma phosphorylated tau 217 and phosphorylated tau 181 as biomarkers in Alzheimer's disease and frontotemporal lobar degeneration: a retrospective diagnostic performance study. Lancet Neurol. 2021 Sep;20(9):739-752. doi: 10.1016/S1474-4422(21)00214-3.
- Derived from this study: PubMed 42832237Estragues-Gazquez I, Contador J, Martinez LD, Fernandez-Lebrero A, Garcia-Escobar G, Navalpotro-Gomez I, Grau-Rivera O, Iaccarino G, Manero-Borras RM, Ortiz-Romero P, Hernandez-Villamizar F, Torres-Torronteras J, de Diego-Osaba M, Blasco-Fornies H, Jimenez-Moyano E, Hernandez JJ, Padros A, Del Campo M, Puig-Pijoan A, Suarez-Calvet M. Earlier Disclosure of Blood-Based Biomarkers, Diagnostic Certainty, and Clinical Management: A Randomized Clinical Trial. JAMA Neurol. 2026 Oct 5:e263497. doi: 10.1001/jamaneurol.2026.3497. Online ahead of print.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Suárez-Calvet, MD PhD principal investigator
Hospital del Mar Research Insititute (IMIM)
Albert Puig-Pijoan, MD principal investigator
Hospital del Mar Research Insititute (IMIM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Cognitive Impairment, run by Hospital del Mar Research Institute (IMIM) at 1 site in Spain.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Etiological diagnosis (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT06246019, which also lists 8 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 28 Feb 2024.