Alzheimer DiseaseDREAMERNCT05614310
Detecting Early Alzheimer's Using MR
An observational study of Alzheimer Disease, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Alzheimer's disease (AD) is the most common cause of dementia, affecting approximately 10% of individuals aged ≥ 65. Most available treatments aim at controlling symptoms at an early stage rather than providing a cure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Magnetic Resonance Imaging (MRI), Blood Glucose Assessment and Positron Emission Tomography (PET)
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2022to 31 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Target population: For the methods development phase, 20 healthy volunteers (age 18 years and above) without contra-indications to MRI will be recruited. Twenty patients with clinically diagnosed AD and 20 age-matched controls (+/- 3 years) will be recruited to test the clinical feasibility of glucoCEST. As a feasibility study, the current work is unlikely to cover the full representative range of AD patients with diverse phenotypes. Its key purpose is to explore whether the proposed technique will show different glucose uptake between those with normal cognition and those with early AD. Further the purpose of future clinical use will be to detect AD in its early stage where clinical manifestations of AD are either subclinical or very mild. We will ensure that the sample is representative of the age range of AD patients, as well as sex balanced.
Who may be able to join
- Development phase:
- Controls (development group) must:
- be > 18 years
- consent to the study
- not report problems with memory.
- Clinical phase
Show all 15Show fewer
- Patients must:
- be ≥ 65 years,
- able to provide informed consent to the study
- have been clinically diagnosed with AD by the mental health team.
- Controls must:
- be ≥ 65 years
- able to provide consent to the study
- have a normal score in the ADAS-cog test and the Mini Mental State Examination test (MMSE)
- not report problems with memory.
Who cannot join
- Subjects will not be considered if they:
- have a history of diabetes,
- have history of a major stroke (mini-stroke/Transient Ischaemic Attacks or lacunar stroke are acceptable),
- have contra-indications to MRI scanning such as implantable cardiac devices
- have family history in AD, to exclude possible gene mutations associated with AD
- have advanced AD who lack the capacity to consent.
- Are pregnant (for developmental phase)
- are unable to read or speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Aberdeen
Aberdeen, AB24 3FX
Gordon Waiter, PhD, +44 (0)1224 438356, g.waiter@abdn.ac.uk
Nicholas Senn de Vries, PhD, +44 (0)1224 438352, nicholas.senn2@abdn.ac.uk
About this study
Official title: Early Detection Of Alzheimer's Disease With GlucoCEST MRI: A Feasibility Study.
Alzheimer's disease (AD) is the most common cause of dementia, affecting approximately 10% of individuals aged ≥ 65. Most available treatments aim at controlling symptoms at an early stage rather than providing a cure. Therefore, an accurate and early diagnosis of AD with appropriate management will slow the progression of the condition. Reduced cerebral glucose levels have been observed in patients with early AD. Glucose hypometabolism can be assessed by administering a radioactive glucose analogue, 2-deoxy-2-(18F) fluoro-D-glucose (18FDG), and imaging with PET (positron emission tomography). The high cost and limited availability of PET-CT (PET - computed tomography) still hamper its general clinical application. Moreover, the use of radioactive tracers in combination with the additional ionizing radiation of CT is not suitable for repeated measurements. Therefore, currently, the provisional diagnosis of AD is still based on the combination of clinical history, neurological examination, cognitive testing over a period of time, and structural neuroimaging. This has major time and resource implications.
A radically different and highly innovative means for imaging glucose with magnetic resonance imaging (MRI) has now been established, exploiting the interaction between hydroxyl protons in glucose and the protons in water; the method is termed glucose Chemical Exchange Saturation Transfer (glucoCEST). GlucoCEST MRI is a method that has no reliance on radiolabelled glucose analogues and could become widely implemented in clinic practice. We therefore aim to investigate the potential of glucoCEST MRI in Alzheimer's disease.
Read the detailed description
Alzheimer's disease (AD) is the most common cause of dementia, affecting approximately 10% of individuals aged ≥ 65. Most available treatments aim at controlling symptoms at an early stage rather than providing a cure. Therefore, an accurate and early diagnosis of AD with appropriate management will slow the progression of the condition. Reduced cerebral glucose levels have been observed in patients with early AD. Glucose hypometabolism can be assessed by administering a radioactive glucose analogue, 2-deoxy-2-(18F) fluoro-D-glucose (18FDG), and imaging with PET (positron emission tomography). The high cost and limited availability of PET-CT (PET - computed tomography) still hamper its general clinical application. Moreover, the use of radioactive tracers in combination with the additional ionizing radiation of CT is not suitable for repeated measurements. Therefore, currently, the provisional diagnosis of AD is still based on the combination of clinical history, neurological examination, cognitive testing over a period of time, and structural neuroimaging. This has major time and resource implications.
A radically different and highly innovative means for imaging glucose with magnetic resonance imaging (MRI) has now been established, exploiting the interaction between hydroxyl protons in glucose and the protons in water; the method is termed glucose Chemical Exchange Saturation Transfer (glucoCEST). GlucoCEST MRI is a method that has no reliance on radiolabelled glucose analogues and could become widely implemented in clinic practice. We believe that glucoCEST MRI has the potential to replace FDG-PET and improve patient healthcare as part of a routine clinical pathway in very early detection of AD.
The study will include 20 healthy volunteers for developing glucoCEST in the clinical 3T MRI scanner (development phase) and 20 volunteers without AD and 20 patients with clinically diagnosed AD (clinical phase). All participants will have a 3T brain MRI scan after they receive oral glucose. The participants in the clinical phase will have a 3T brain MRI scan, a brain PET scan and they will also undertake two cognitive tests.
The glucose uptake and clearance rate in the brain will be measured from PET and MRI scans and compared between groups and imaging modalities. Sensitivity and specificity of glucoCEST to detect AD will be also calculated.
Primary Objective: To estimate the sensitivity of glucose uptake as measured by glucoCEST MRI in patients with AD compared with age and sex matched controls.
Secondary objective: To investigate if the glucose uptake as measured by glucoCEST MRI is related to the glucose uptake as measured in FDG-PET.
The main aims of the study are:
- To determine normal uptake and clearance rates of glucose in the brain as measured by dynamic glucoCEST MRI at 3T
- To compare glucose uptake as measured by glucoCEST MRI and FDG-PET.
- To compare glucose uptake as measured by glucoCEST MRI in patients with AD and age and sex matched controls.
- Conditions
- Alzheimer Disease
- Being tested
- Magnetic Resonance Imaging (MRI), Blood Glucose Assessment, Positron Emission Tomography (PET), Cognitive Assessment
- Keywords
- Magnetic Resonance Imaging (MRI), Glucose Chemical Exchange Saturation Transfer (CEST)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
Participants will be asked to lie in the MRI scanner while we collect 3D T1- and T2-weighted images and a 3D FLAIR image to exclude pathology (e.g. stroke). Participants will ingest a glucose solution (75 g Dextrose) so dynamic glucoCEST images can be acquired to measure glucose uptake and clearance.
Blood Glucose AssessmentOther
A blood testing meter will be used to measure the blood sugar levels before and after the scans. Normal reading for a nondiabetic person after fasting is 70-99 mg/dl (3.9-6 mmol/L). If abnormal blood sugar levels are detected (sugar levels outside the above normal range), the participant will no longer be eligible for the study and they will be withdrawn.
Positron Emission Tomography (PET)Other
Participants will be administered a radioactive glucose analogue, 2-deoxy-2-(18F) fluoro-D-glucose (18FDG) through a canula inserted into a vein in the arm or hand and asked to sit quietly for 1 h. After 1 h they will be asked to lie quietly and without talking in the PET scanner and a PET brain scan will be performed.
Cognitive AssessmentOther
Participants will be asked to undertake two cognitive tests (the Alzheimer's Disease Assessment Scale ADAS-cog test and the Mini Mental State Examination test - MMSE). These are standard clinical tests used to determine cognitive dysfunction in Alzheimer's disease.
| Study group | Role | What they receive |
|---|---|---|
| Development Group 1 (N = 10) (Development Phase) | Development group participants (N = 10) will undergo 1 magnetic resonance imaging (MRI) sessions. Before and after their MRI scan participants will be given a pinprick blood sugar test. Receives: Other: Magnetic Resonance Imaging (MRI); Other: Blood Glucose Assessment | |
| Patients (N = 20) (Clinical Phase) | Patients (N = 20) will attend 2 visits up to 1 week apart. Patients will be asked to have a no-sugar diet and take no exercise for 24 hours before each visit and to avoid eating 6 hours before scan.
Visit 1: Patients will undergo a positron emission tomography (PET) assessment. Before and after their PET assessment patients will be given a pinprick blood sugar test. PET assessment:
Visit 2: Patients will undergo MRI assessment. Before and after their MRI scan patients will be given a pinprick blood sugar test. Healthy controls will complete cognitive assessments. Receives: Other: Magnetic Resonance Imaging (MRI); Other: Blood Glucose Assessment; Other: Positron Emission Tomography (PET); Other: Cognitive Assessment | |
| Healthy Controls (N = 20) (Clinical Phase) | Healthy controls (N = 20) will attend 2 visits up to 1 week apart. Healthy controls will be age matched (+/- 3 years) and sex matched to the patient group. Healthy controls will be asked to have a no-sugar diet and take no exercise for 24 hours before each visit and to avoid eating 6 hours before scan.
Visit 1: Healthy Controls will undergo a positron emission tomography (PET) assessment. Before and after their PET assessment patients will be given a pinprick blood sugar test. PET assessment:
Visit 2: Healthy Controls will undergo MRI assessment. Before and after their MRI scan patients will be given a pinprick blood sugar test. Healthy controls will complete cognitive assessments. Receives: Other: Magnetic Resonance Imaging (MRI); Other: Blood Glucose Assessment; Other: Positron Emission Tomography (PET); Other: Cognitive Assessment | |
| Development Group 2 (N = 10) (Development Phase) | To investigate the repeatability of MRI assessment, 10 development phase healthy volunteers will be recruited to undergo two repeated study assessments. The second visit will be between 7 and 14 days after their first visit. The second repeated study assessment will follow the same procedure as the first visit, consisting of blood glucose assessment and MRI assessment. Participants will be advised to fast from mid-night and avoid eating breakfast. Receives: Other: Magnetic Resonance Imaging (MRI); Other: Blood Glucose Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET glucose measurement
Dynamic frames from FDG-PET will be summed and normalised to the cerebellum using MATLAB (MathWorks Inc., USA). Standardised uptake values (SUVs) from PET will then be calculated. Regions of interests (ROIs) will derived from normalisation to the standard Desikan Killiany atlas. Average SUV from PET will be calculated from each ROI in MATLAB.
Glucose uptake (maximum ΔS/So) with units of ratio.
Clearance (rate of decrease of ΔS/So) values with units of ratio.
Measured: 2 years
CEST-MRI glucose measurement
Dynamic frames from CEST MRI will be summed and normalised to the cerebellum using MATLAB (MathWorks Inc., USA). Standardised uptake values (SUVs) will be calculated in regions of interests (ROIs) derived from normalisation to the standard Desikan Killiany atlas. Average SUV from each ROI, the glucose uptake (maximum ΔS/So) and clearance (rate of decrease of ΔS/So) values from patients and controls will be calculated using MATLAB.
Glucose uptake (maximum ΔS/So) with units of ratio.
Clearance (rate of decrease of ΔS/So) values with units of ratio
Measured: 2 years
Sensitivity and specificity of CEST-MRI glucose measurements
A neuroradiologist blinded to the diagnosis of each participant will be asked to report the scans in a similar way to an FDG-PET scan. Sensitivity and specificity of glucoCEST to detect AD by estimating the proportion of true positives and true negatives respectively will be determined. To demonstrate the feasibility of glucoCEST in differentiating AD patients from controls, group comparisons of glucose (paired samples t-tests as implemented by SPSS) uptake values between patients and controls and of glucose clearance values between patients and controls will be performed.
Sensitivity and specificity values with units of ratio.
Measured: 2 years
Repeatability of CEST-MRI glucose measurement
To investigate the repeatability of MRI assessment, 10 out of 20 development phase healthy volunteers will be recruited to undergo a second repeated study assessment visit between 7 and 14 days after their first visit.
Coefficient of variation values with units of percent.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Nov 2022
- Primary completion31 Dec 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 (6)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Gordon Waiter, PhD, Study chair, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614310
- Sponsor's protocol ID
- 2-001-22
- Other IDs
- TCS/21/03, 22\LO\0347, 308185
- Acronym
- DREAMER
- Status last verified
- Mar 2025
- First submitted
- 3 Nov 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kukull WA, Higdon R, Bowen JD, McCormick WC, Teri L, Schellenberg GD, van Belle G, Jolley L, Larson EB. Dementia and Alzheimer disease incidence: a prospective cohort study. Arch Neurol. 2002 Nov;59(11):1737-46. doi: 10.1001/archneur.59.11.1737.
PubMed 12433261Bloudek LM, Spackman DE, Blankenburg M, Sullivan SD. Review and meta-analysis of biomarkers and diagnostic imaging in Alzheimer's disease. J Alzheimers Dis. 2011;26(4):627-45. doi: 10.3233/JAD-2011-110458.
PubMed 21694448Marcus C, Mena E, Subramaniam RM. Brain PET in the diagnosis of Alzheimer's disease. Clin Nucl Med. 2014 Oct;39(10):e413-22; quiz e423-6. doi: 10.1097/RLU.0000000000000547.
PubMed 25199063Tolomeo D, Micotti E, Serra SC, Chappell M, Snellman A, Forloni G. Chemical exchange saturation transfer MRI shows low cerebral 2-deoxy-D-glucose uptake in a model of Alzheimer's Disease. Sci Rep. 2018 Jun 22;8(1):9576. doi: 10.1038/s41598-018-27839-7.
PubMed 29934551Wang J, Weygand J, Hwang KP, Mohamed AS, Ding Y, Fuller CD, Lai SY, Frank SJ, Zhou J. Magnetic Resonance Imaging of Glucose Uptake and Metabolism in Patients with Head and Neck Cancer. Sci Rep. 2016 Jul 27;6:30618. doi: 10.1038/srep30618.
PubMed 27461165Kim M, Torrealdea F, Adeleke S, Rega M, Evans V, Beeston T, Soteriou K, Thust S, Kujawa A, Okuchi S, Isaac E, Piga W, Lambert JR, Afaq A, Demetriou E, Choudhary P, Cheung KK, Naik S, Atkinson D, Punwani S, Golay X. Challenges in glucoCEST MR body imaging at 3 Tesla. Quant Imaging Med Surg. 2019 Oct;9(10):1628-1640. doi: 10.21037/qims.2019.10.05.
PubMed 31728307
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection Of Alzheimer's Disease With GlucoCEST MRI: A Feasibility Study.
- ClinicalTrials.gov ID
- NCT05614310
- Acronym / sponsor ID
- DREAMER / 2-001-22
- Conditions
- Alzheimer Disease
- Keywords
- Magnetic Resonance Imaging (MRI), Glucose Chemical Exchange Saturation Transfer (CEST)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Nov 2022 (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.
Alzheimer's disease (AD) is the most common cause of dementia, affecting approximately 10% of individuals aged ≥ 65. Most available treatments aim at controlling symptoms at an early stage rather than providing a cure. Therefore, an accurate and early diagnosis of AD with appropriate management will slow the progression of the condition. Reduced cerebral glucose levels have been observed in patients with early AD. Glucose hypometabolism can be assessed by administering a radioactive glucose analogue, 2-deoxy-2-(18F) fluoro-D-glucose (18FDG), and imaging with PET (positron emission tomography). The high cost and limited availability of PET-CT (PET - computed tomography) still hamper its general clinical application. Moreover, the use of radioactive tracers in combination with the additional ionizing radiation of CT is not suitable for repeated measurements. Therefore, currently, the provisional diagnosis of AD is still based on the combination of clinical history, neurological examination, cognitive testing over a period of time, and structural neuroimaging. This has major time and resource implications.
A radically different and highly innovative means for imaging glucose with magnetic resonance imaging (MRI) has now been established, exploiting the interaction between hydroxyl protons in glucose and the protons in water; the method is termed glucose Chemical Exchange Saturation Transfer (glucoCEST). GlucoCEST MRI is a method that has no reliance on radiolabelled glucose analogues and could become widely implemented in clinic practice. We therefore aim to investigate the potential of glucoCEST MRI in Alzheimer's disease.
Detailed description
Alzheimer's disease (AD) is the most common cause of dementia, affecting approximately 10% of individuals aged ≥ 65. Most available treatments aim at controlling symptoms at an early stage rather than providing a cure. Therefore, an accurate and early diagnosis of AD with appropriate management will slow the progression of the condition. Reduced cerebral glucose levels have been observed in patients with early AD. Glucose hypometabolism can be assessed by administering a radioactive glucose analogue, 2-deoxy-2-(18F) fluoro-D-glucose (18FDG), and imaging with PET (positron emission tomography). The high cost and limited availability of PET-CT (PET - computed tomography) still hamper its general clinical application. Moreover, the use of radioactive tracers in combination with the additional ionizing radiation of CT is not suitable for repeated measurements. Therefore, currently, the provisional diagnosis of AD is still based on the combination of clinical history, neurological examination, cognitive testing over a period of time, and structural neuroimaging. This has major time and resource implications.
A radically different and highly innovative means for imaging glucose with magnetic resonance imaging (MRI) has now been established, exploiting the interaction between hydroxyl protons in glucose and the protons in water; the method is termed glucose Chemical Exchange Saturation Transfer (glucoCEST). GlucoCEST MRI is a method that has no reliance on radiolabelled glucose analogues and could become widely implemented in clinic practice. We believe that glucoCEST MRI has the potential to replace FDG-PET and improve patient healthcare as part of a routine clinical pathway in very early detection of AD.
The study will include 20 healthy volunteers for developing glucoCEST in the clinical 3T MRI scanner (development phase) and 20 volunteers without AD and 20 patients with clinically diagnosed AD (clinical phase). All participants will have a 3T brain MRI scan after they receive oral glucose. The participants in the clinical phase will have a 3T brain MRI scan, a brain PET scan and they will also undertake two cognitive tests.
The glucose uptake and clearance rate in the brain will be measured from PET and MRI scans and compared between groups and imaging modalities. Sensitivity and specificity of glucoCEST to detect AD will be also calculated.
Primary Objective: To estimate the sensitivity of glucose uptake as measured by glucoCEST MRI in patients with AD compared with age and sex matched controls.
Secondary objective: To investigate if the glucose uptake as measured by glucoCEST MRI is related to the glucose uptake as measured in FDG-PET.
The main aims of the study are:
- To determine normal uptake and clearance rates of glucose in the brain as measured by dynamic glucoCEST MRI at 3T
- To compare glucose uptake as measured by glucoCEST MRI and FDG-PET.
- To compare glucose uptake as measured by glucoCEST MRI in patients with AD and age and sex matched controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Development Group 1 (N = 10) (Development Phase) | – | Other: Magnetic Resonance Imaging (MRI), Other: Blood Glucose AssessmentDevelopment group participants (N = 10) will undergo 1 magnetic resonance imaging (MRI) sessions. Before and after their MRI scan participants will be given a pinprick blood sugar test. |
| Patients (N = 20) (Clinical Phase) | – | Other: Magnetic Resonance Imaging (MRI), Other: Blood Glucose Assessment, Other: Positron Emission Tomography (PET), Other: Cognitive AssessmentPatients (N = 20) will attend 2 visits up to 1 week apart. Patients will be asked to have a no-sugar diet and take no exercise for 24 hours before each visit and to avoid eating 6 hours before scan. Visit 1: Patients will undergo a positron emission tomography (PET) assessment. Before and after their PET assessment patients will be given a pinprick blood sugar test. PET assessment: Visit 2: Patients will undergo MRI assessment. Before and after their MRI scan patients will be given a pinprick blood sugar test. Healthy controls will complete cognitive assessments. |
| Healthy Controls (N = 20) (Clinical Phase) | – | Other: Magnetic Resonance Imaging (MRI), Other: Blood Glucose Assessment, Other: Positron Emission Tomography (PET), Other: Cognitive AssessmentHealthy controls (N = 20) will attend 2 visits up to 1 week apart. Healthy controls will be age matched (+/- 3 years) and sex matched to the patient group. Healthy controls will be asked to have a no-sugar diet and take no exercise for 24 hours before each visit and to avoid eating 6 hours before scan. Visit 1: Healthy Controls will undergo a positron emission tomography (PET) assessment. Before and after their PET assessment patients will be given a pinprick blood sugar test. PET assessment: Visit 2: Healthy Controls will undergo MRI assessment. Before and after their MRI scan patients will be given a pinprick blood sugar test. Healthy controls will complete cognitive assessments. |
| Development Group 2 (N = 10) (Development Phase) | – | Other: Magnetic Resonance Imaging (MRI), Other: Blood Glucose AssessmentTo investigate the repeatability of MRI assessment, 10 development phase healthy volunteers will be recruited to undergo two repeated study assessments. The second visit will be between 7 and 14 days after their first visit. The second repeated study assessment will follow the same procedure as the first visit, consisting of blood glucose assessment and MRI assessment. Participants will be advised to fast from mid-night and avoid eating breakfast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Target population: For the methods development phase, 20 healthy volunteers (age 18 years and above) without contra-indications to MRI will be recruited. Twenty patients with clinically diagnosed AD and 20 age-matched controls (+/- 3 years) will be recruited to test the clinical feasibility of glucoCEST. As a feasibility study, the current work is unlikely to cover the full representative range of AD patients with diverse phenotypes. Its key purpose is to explore whether the proposed technique will show different glucose uptake between those with normal cognition and those with early AD. Further the purpose of future clinical use will be to detect AD in its early stage where clinical manifestations of AD are either subclinical or very mild. We will ensure that the sample is representative of the age range of AD patients, as well as sex balanced.
Key inclusion criteria (15 listed)
- be > 18 years
- consent to the study
- not report problems with memory.
- Clinical phase
- be ≥ 65 years,
Key exclusion criteria (8 listed)
- have a history of diabetes,
- have history of a major stroke (mini-stroke/Transient Ischaemic Attacks or lacunar stroke are acceptable),
- have contra-indications to MRI scanning such as implantable cardiac devices
- have family history in AD, to exclude possible gene mutations associated with AD
- have advanced AD who lack the capacity to consent.
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Participants will be asked to lie in the MRI scanner while we collect 3D T1- and T2-weighted images and a 3D FLAIR image to exclude pathology (e.g. stroke). Participants will ingest a glucose solution (75 g Dextrose) so dynamic glucoCEST images can be acquired to measure glucose uptake and clearance. | Other | Development Group 1 (N = 10) (Development Phase), Development Group 2 (N = 10) (Development Phase), Healthy Controls (N = 20) (Clinical Phase), Patients (N = 20) (Clinical Phase) |
| Blood Glucose AssessmentA blood testing meter will be used to measure the blood sugar levels before and after the scans. Normal reading for a nondiabetic person after fasting is 70-99 mg/dl (3.9-6 mmol/L). If abnormal blood sugar levels are detected (sugar levels outside the above normal range), the participant will no longer be eligible for the study and they will be withdrawn. | Other | Development Group 1 (N = 10) (Development Phase), Development Group 2 (N = 10) (Development Phase), Healthy Controls (N = 20) (Clinical Phase), Patients (N = 20) (Clinical Phase) |
| Positron Emission Tomography (PET)Participants will be administered a radioactive glucose analogue, 2-deoxy-2-(18F) fluoro-D-glucose (18FDG) through a canula inserted into a vein in the arm or hand and asked to sit quietly for 1 h. After 1 h they will be asked to lie quietly and without talking in the PET scanner and a PET brain scan will be performed. | Other | Healthy Controls (N = 20) (Clinical Phase), Patients (N = 20) (Clinical Phase) |
| Cognitive AssessmentParticipants will be asked to undertake two cognitive tests (the Alzheimer's Disease Assessment Scale ADAS-cog test and the Mini Mental State Examination test - MMSE). These are standard clinical tests used to determine cognitive dysfunction in Alzheimer's disease. | Other | Healthy Controls (N = 20) (Clinical Phase), Patients (N = 20) (Clinical Phase) |
Primary outcome
PET glucose measurement
Time frame: 2 years
Dynamic frames from FDG-PET will be summed and normalised to the cerebellum using MATLAB (MathWorks Inc., USA). Standardised uptake values (SUVs) from PET will then be calculated. Regions of interests (ROIs) will derived from normalisation to the standard Desikan Killiany atlas. Average SUV from PET will be calculated from each ROI in MATLAB. Glucose uptake (maximum ΔS/So) with units of ratio. Clearance (rate of decrease of ΔS/So) values with units of ratio.
CEST-MRI glucose measurement
Time frame: 2 years
Dynamic frames from CEST MRI will be summed and normalised to the cerebellum using MATLAB (MathWorks Inc., USA). Standardised uptake values (SUVs) will be calculated in regions of interests (ROIs) derived from normalisation to the standard Desikan Killiany atlas. Average SUV from each ROI, the glucose uptake (maximum ΔS/So) and clearance (rate of decrease of ΔS/So) values from patients and controls will be calculated using MATLAB. Glucose uptake (maximum ΔS/So) with units of ratio. Clearance (rate of decrease of ΔS/So) values with units of ratio
Sensitivity and specificity of CEST-MRI glucose measurements
Time frame: 2 years
A neuroradiologist blinded to the diagnosis of each participant will be asked to report the scans in a similar way to an FDG-PET scan. Sensitivity and specificity of glucoCEST to detect AD by estimating the proportion of true positives and true negatives respectively will be determined. To demonstrate the feasibility of glucoCEST in differentiating AD patients from controls, group comparisons of glucose (paired samples t-tests as implemented by SPSS) uptake values between patients and controls and of glucose clearance values between patients and controls will be performed. Sensitivity and specificity values with units of ratio.
Repeatability of CEST-MRI glucose measurement
Time frame: 2 years
To investigate the repeatability of MRI assessment, 10 out of 20 development phase healthy volunteers will be recruited to undergo a second repeated study assessment visit between 7 and 14 days after their first visit. Coefficient of variation values with units of percent.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 12433261Kukull WA, Higdon R, Bowen JD, McCormick WC, Teri L, Schellenberg GD, van Belle G, Jolley L, Larson EB. Dementia and Alzheimer disease incidence: a prospective cohort study. Arch Neurol. 2002 Nov;59(11):1737-46. doi: 10.1001/archneur.59.11.1737.
- Background: PubMed 21694448Bloudek LM, Spackman DE, Blankenburg M, Sullivan SD. Review and meta-analysis of biomarkers and diagnostic imaging in Alzheimer's disease. J Alzheimers Dis. 2011;26(4):627-45. doi: 10.3233/JAD-2011-110458.
- Background: PubMed 25199063Marcus C, Mena E, Subramaniam RM. Brain PET in the diagnosis of Alzheimer's disease. Clin Nucl Med. 2014 Oct;39(10):e413-22; quiz e423-6. doi: 10.1097/RLU.0000000000000547.
- Background: PubMed 29934551Tolomeo D, Micotti E, Serra SC, Chappell M, Snellman A, Forloni G. Chemical exchange saturation transfer MRI shows low cerebral 2-deoxy-D-glucose uptake in a model of Alzheimer's Disease. Sci Rep. 2018 Jun 22;8(1):9576. doi: 10.1038/s41598-018-27839-7.
- Background: PubMed 27461165Wang J, Weygand J, Hwang KP, Mohamed AS, Ding Y, Fuller CD, Lai SY, Frank SJ, Zhou J. Magnetic Resonance Imaging of Glucose Uptake and Metabolism in Patients with Head and Neck Cancer. Sci Rep. 2016 Jul 27;6:30618. doi: 10.1038/srep30618.
- Background: PubMed 31728307Kim M, Torrealdea F, Adeleke S, Rega M, Evans V, Beeston T, Soteriou K, Thust S, Kujawa A, Okuchi S, Isaac E, Piga W, Lambert JR, Afaq A, Demetriou E, Choudhary P, Cheung KK, Naik S, Atkinson D, Punwani S, Golay X. Challenges in glucoCEST MR body imaging at 3 Tesla. Quant Imaging Med Surg. 2019 Oct;9(10):1628-1640. doi: 10.21037/qims.2019.10.05.
- Individual participant dataSharing planned: No
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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.
Gordon Waiter, PhD study chair
University of Aberdeen
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, run by University of Aberdeen at 1 site 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 15 inclusion and 8 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 30 Mar 2025. 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 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?
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 Gordon Waiter, PhD (+44 (0)1224 438356, g.waiter@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET glucose measurement (time frame: 2 years). The study lists 4 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 NCT05614310, which also lists 6 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 30 Mar 2025.