Dementia (Diagnosis)NCT03861884
Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)
An observational study of Dementia (Diagnosis), run by Nottingham University Hospitals NHS Trust at 2 sites in United Kingdom.
Trial summary
This prospective study aims: 1. to compare cognitive performance in different clinical groups of participants with mild cognitive impairment (MCI) or mild dementia [Alzheimer's Disease (AD), Vascular Cognitive Impairment (VCI) and Fronto-temporal Dementia (FTD)] to determine whether scores reveal differential profiles… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia (Diagnosis)
- What is being tested?
- Cognitive assessments
- How many people
- 125 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Dec 2018to Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Alzheimer's disease, Frontotemporal dementia, Vascular Cognitive Impairment
Who may be able to join
- Ability to give informed consent.
- Either pathological, genetic or imaging biomarker evidence to suggest Fronto-temporal Lobar Degeneration, Alzheimer's Disease or Vascular Cognitive Impairment, or defined clinical diagnoses.
Who cannot join
- Lack of mental capacity to consent to study involvement.
- Not speaking English before age 5 years.
- Learning disability.
- MRI contraindications
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 1 recruiting
- Completed
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, Easat Midland, NG7 2TU
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, East Midland, NG7 2UH
Haley Morris, Haley.Morris@nuh.nhs.uk
Julie Lynch, Julie.Lynch@nuh.nhs.uk
About this study
This prospective study aims:
- to compare cognitive performance in different clinical groups of participants with mild cognitive impairment (MCI) or mild dementia [Alzheimer's Disease (AD), Vascular Cognitive Impairment (VCI) and Fronto-temporal Dementia (FTD)] to determine whether scores reveal differential profiles between the groups,
- to demonstrate differences in imaging markers between different dementia syndromes and healthy volunteers using ultra high-field MRI at 7T.
Read the detailed description
The imaging arm of the study include:
- to demonstrate differences in brain iron levels between different dementia syndromes and healthy volunteers using ultra high-field MRI, quantitative susceptibility mapping (QSM) at 7T.
- to demonstrate variations in the resting oxygen usage as an important biomarker to discriminate between different dementia syndromes.
- to demonstrate cerebral blood flow changes in the brain, particularly in the hippocampus region, and its correlation with different dementia syndromes using Arterial Spin Labelling MRI technique.
- to demonstrate increased blood brain barrier leakage in the brain, particularly in the hippocampus region, and its correlation with Alzheimer's Disease (AD) and Vascular Cognitive Impairment (VCI) using a new dynamic contrast-enhanced MRI (DCE-MRI) technique.
- Conditions
- Dementia (Diagnosis)
- Being tested
- Cognitive assessments
- Medical subject headings
- Dementia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive assessmentsDiagnostic test
Also called MRI at 3T, MRI at 7T
Cognitive assessment and MRI at 3T and/or 7T
| Study group | Role | What they receive |
|---|---|---|
| Cognitive assessments | Neurocognitive assessments, Birmingham Cognitive Screen | |
| MRI at 3T | Brain Imaging: MRI at 3T Receives: Diagnostic Test: Cognitive assessments | |
| MRI at 7T | Brain imaging: Ultrahigh Field MRI at 7T Receives: Diagnostic Test: Cognitive assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive scales on Birmingham Cognitive Screen (BCoS) Scores
cognitive sub scores in relation to clinical phenotype
Measured: Through study completion (an average of one year)
Secondary outcomes (2)
Structural imaging changes on MRI at 3T
Structural volume loss
Measured: Through study completion (an average of one year)
Susceptibility weighted mapping at 7T
Quantitative Susceptibility Mapping
Measured: Through study completion (an average of one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start12 Dec 2018
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia (Diagnosis)Studies 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akram Hosseini, MD, PhD, Principal investigator, Akram.Hosseini@nuh.nhs.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861884
- Sponsor's protocol ID
- 18NS001
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2019
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)
- ClinicalTrials.gov ID
- NCT03861884
- Acronym / sponsor ID
- 18NS001
- Conditions
- Dementia (Diagnosis)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 4 Mar 2019 (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.
This prospective study aims:
- to compare cognitive performance in different clinical groups of participants with mild cognitive impairment (MCI) or mild dementia [Alzheimer's Disease (AD), Vascular Cognitive Impairment (VCI) and Fronto-temporal Dementia (FTD)] to determine whether scores reveal differential profiles between the groups,
- to demonstrate differences in imaging markers between different dementia syndromes and healthy volunteers using ultra high-field MRI at 7T.
Detailed description
The imaging arm of the study include:
- to demonstrate differences in brain iron levels between different dementia syndromes and healthy volunteers using ultra high-field MRI, quantitative susceptibility mapping (QSM) at 7T.
- to demonstrate variations in the resting oxygen usage as an important biomarker to discriminate between different dementia syndromes.
- to demonstrate cerebral blood flow changes in the brain, particularly in the hippocampus region, and its correlation with different dementia syndromes using Arterial Spin Labelling MRI technique.
- to demonstrate increased blood brain barrier leakage in the brain, particularly in the hippocampus region, and its correlation with Alzheimer's Disease (AD) and Vascular Cognitive Impairment (VCI) using a new dynamic contrast-enhanced MRI (DCE-MRI) technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive assessments | – | –Neurocognitive assessments, Birmingham Cognitive Screen |
| MRI at 3T | – | Diagnostic Test: Cognitive assessmentsBrain Imaging: MRI at 3T |
| MRI at 7T | – | Diagnostic Test: Cognitive assessmentsBrain imaging: Ultrahigh Field MRI at 7T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Alzheimer's disease, Frontotemporal dementia, Vascular Cognitive Impairment
Key inclusion criteria (2 listed)
- Ability to give informed consent.
- Either pathological, genetic or imaging biomarker evidence to suggest Fronto-temporal Lobar Degeneration, Alzheimer's Disease or Vascular Cognitive Impairment, or defined clinical diagnoses.
Key exclusion criteria (4 listed)
- Lack of mental capacity to consent to study involvement.
- Not speaking English before age 5 years.
- Learning disability.
- MRI contraindications
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 |
|---|---|---|
| Cognitive assessmentsAlso: MRI at 3T, MRI at 7TCognitive assessment and MRI at 3T and/or 7T | Diagnostic test | MRI at 3T, MRI at 7T |
Primary outcome
Neurocognitive scales on Birmingham Cognitive Screen (BCoS) Scores
Time frame: Through study completion (an average of one year)
cognitive sub scores in relation to clinical phenotype
2 secondary outcomes
Structural imaging changes on MRI at 3T
Time frame: Through study completion (an average of one year)
Susceptibility weighted mapping at 7T
Time frame: Through study completion (an average of one year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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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.
Akram Hosseini, MD, PhD principal investigator
Akram.Hosseini@nuh.nhs.uk
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia (Diagnosis), run by Nottingham University Hospitals NHS Trust at 2 sites in United Kingdom.
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 2 inclusion and 4 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Contact Akram Dr Hosseini (0115 924 9924 ext. 66410, Akram.Hosseini@nuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive scales on Birmingham Cognitive Screen (BCoS) Scores (time frame: Through study completion (an average of one year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2024.