Dementia and memory studies

Summary

Investigate changes seen in the brains of individuals with DLB compared to healthy older-adults using 7T MRI. Participants undergo cognitive & clinical examinations and have blood tests taken. Aim to greater understand DLB and develop treatments

Inclusion criteria

General criteria for all participants.

1. Aged 60+ 
2. Male and female 
3. Have capacity to give informed consent to participate in study 
4. Have a sufficient grasp of English to allow standardised cognitive testing


In addition to the general inclusion criteria, individuals in the DLB study group will: 
Fulfil the DLB consortium criteria (stated in McKeith, I. G., et al., 2005. Diagnosis and management of dementia with Lewy bodies: third report of the DLB Consortium. Neurology Journals. 65(12): 1863-1872)
Have mild/moderate dementia, as participants with greater impairment than this are unlikely to be able to comply with study procedures. Degree of dementia will be determined according to MMSE score (stated in Folstein, M. F., et al., 1975. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research 12(3): 189-198), which should be a minimum of 12/30
Have a reliable informant (e.g., a spouse), who is well-known to the DLB participant and agrees to complete questionnaires for informant-rated scales and provide background history
In addition to the general inclusion criteria, individuals in the control group will:

Be ‘cognitively normal’, determined according to the MMSE score, which should be a minimum of 26/30. ​

Exclusion criteria

1. Concurrent psychiatric or neurological disease (other than DLB in the study group), severe physical illness or co-morbidity that may limit ability to fully participate in the study

2. History of stroke (cerebro-vascular accident)

3. Present of prosthese or other implant which limit the safety or value of image

4. Any contraindication to MRI

Targeted, end date and PI

EPUT: 14

31.12.25

PI: Dr Zuzana Walker 

Study Lead: Elizabeth Phillips

Summary

To collect Cerebral Spinal Fluid (CSF), blood and neuroimaging data from patients with suspected DLB, AD or PDD, expecting the majority will have mild dementia or very early problems like MCI. Full biological sample analysis performed by King’s College London researchers. Additionally to known AD measures, to examine new markers and see if they can accurately predict disease outcomes for DLB. Patient followed for up to 3 years with biological markers completed at the beginning of the study and cognitive tests and questionnaires done annually.

Inclusion criteria

1. Capacity to give informed consent must be present at the beginning of the study. However, should the study participants lose their mental capacity, a consultee will be identified to advise on their continuation to participate in the study.

2. Aged 50+

3. Diagnosed with Dementia with Lewy Bodies (DLB), Parkinson’s disease dementia (PDD) or Alzheimer’s Dementia (AD) or Mild Cognitive Impairment (MCI) according to standardised criteria (as specified in Appendices Number 1, 2, 3 and 4).
Prodromal DLB as previously recommended
MCI with at least one DLB core feature (Bonnani, et al., 2015), idiopathic REM sleep behaviour disorder (RBD), or isolated visual hallucinations (McKeith et al., 2017)
Possible or probable DLB (consensus DLB criteria, (McKeith et al., 2017))

4. Study partner who agrees to participate in the study and accompany the participant to study visits, and complete questionnaires related to the participants wellbeing. Should the study partner withdraw during the study, a new study partners will need to be identified to continue.

5. Participants must be sufficiently proficient in English language to complete cognitive schedules.

Exclusion criteria

1. Severe physical or life-threatening conditions which may limit ability for the subject to participant in the study. This includes cancer or other conditions with suspected survival time less than three years.

2. Other intracranial pathology (stroke, space occupying lesion, previous intracranial surgery).

3. Other physical or psychiatric conditions which may contribute to cognitive impairment.

4. Diagnosis of possible DLB with negative dopamine transporter scan (DaT scan).

5. More than five years use of antipsychotic drugs prior diagnosis.

6. Contraindications to Lumbar Puncture, inc. warfarin and anticoagulant use (except aspirin at doses of up to 100 mg or lower – if patient has consented to lumbar puncture).

7. Study partner who is unable to attend all study visits with the participant.

Targeted, end date and PI

EPUT: 36 

31.08.25

PI: Dr Zuzana Walker 

Study Lead: Lara Horrax

Summary

Alzheimer’s disease Diagnosis And Plasma P-Tau217 – A multi-centre diagnostic randomised controlled trial of disclosure of results of plasma p-tau217 to community memory clinic patients and clinicians in the UK.

Inclusion criteria

1. Age > =  50 years.

2. Referred to NHS memory service, being seen for first appointment.

3. Presence of a cognitive complaint by the patient (and/or study partner).

4. History of progressive decline in the opinion of the investigator.

5. Objective evidence for impairment as evidenced by any of MMSE < 28, MOCA < 28, ACE-III < 90, RUDAS < 28 in an appropriate language.

6. Alzheimer’s disease is a diagnostic consideration, with a presentation of either Mild Cognitive Impairment (MCI) or mild or moderate dementia 

7. Able to nominate a study partner who has regular contact (at least weekly).

8. Willing and able to provide consent (including via a proxy).

Exclusion criteria

1. Normal cognition or subjective complaints that are not supported by cognitive testing.

2. Amyloid status and/or plasma p-tau217 status already known to patient or referring clinician based on prior amyloid PET, CSF analysis or plasma biomarker.

3. Lacks capacity to provide consent at recruitment visit.

Targeted, end date and PI

EPUT: 20 

31.03.2027 

PI: Professor Zuzana Walker 

Study Lead: Rachel Morrell

Summary

CareCoach Study: Testing the clinical and cost-effectiveness of an online support package (CareCoach) for family carers of people living with dementia. 

Family carers will be randomly allocated to either the CareCoach intervention group or the ‘control’ group where they will continue to receive usual care. The intervention (CareCoach) combines learning modules (via an online platform) with support from a ‘coach’ (eg., health/social care worker) remotely. Carers in the intervention group will use CareCoach for 8-weeks with support from a ‘coach’.

Inclusion criteria

– Currently care/support (e.g., informally, unpaid*) for a person living with dementia (may be a partner, family member, in-law, close friend or neighbour). 

– The person living with dementia (all subtypes) has been diagnosed within the last 5 years. 

– 18 years or over.

– Living in the UK.

– Access to a device with a camera and microphone which connects to the internet (e.g., laptop, tablet, smartphone).

– Seeking to learn new skills and knowledge to cope well while caring for a person living with dementia.

– Able to engage in and understand the programme delivered in English (with the help of family interpreter if required).

*Family carers claiming carer’s allowance are not excluded.

Exclusion criteria

– Potential participants with insufficient cognitive abilities to engage with the online programme.

– Potential participants who report feeling overburdened.

– The person living with dementia currently resides in a care home.

– Taking part or recently taken part in research study using a similar behaviour change or psychological intervention. 

– Taken part in CareCoach WP3 feasibility study.

– Is a paid, professional carer.

Multiple members of the same family (e.g., individuals caring for the same person living with dementia) should not sign up for the trial to avoid potential contamination between groups.

Targeted, end date and PI

EPUT: 10

27.02.2026 

PI: Karen Elliott 

Study Lead: Elizabeth Phillips​

Summary

To find out if adding Memantine to Acetylcholinesterase Inhibitors (AChEI) improves overall health and functioning for people with DLB or PDD with two international, double-blind, placebo-controlled, randomised trials to assess the clinical and cost effectiveness. DLB/PDD patients aged 50+ with a MMSE score of ≥8 on a stable AChEI dose will be randomised to 1:1 Memantine or placebo for 52 weeks – both identical in procedure, with the only variant being the disease group. Participants and caregivers/ informants complete assessments at baseline, 26 weeks (primary, secondary and exploratory outcomes) and 52 weeks (secondary and exploratory outcomes).  During these visits, assessments will be completed by the patient and their caregiver/ informant.

Inclusion criteria

​​1. Patients with a diagnosis or clinical consistent with established consensus criteria for probable DLB or probable PDD.

2. Aged 50+ (no upper limit)

3. Mini Mental State Examination (MMSE) score ≥8 (evidence of mild, moderate or moderate to severe (e.g., scoring 8-12/30) cognitive impairment or similar global cognitive scales (e.g., Addenbrooke’s Cognitive Examination, Mini-Addenbrooke’s Cognitive Examination, Montreal Cognitive Assessment) can be used to pre-screen the patient, prior to approach). 

4. Receiving a stable dose of AChEI for ≥12 weeks prior to baseline, with no expected plans for dose adjustment during the trial period; dose adjustment will be allowed during the trial, if clinically indicated, following discussion with PI and, if required, the central trial team.

5. If receiving any anti-parkinsonian treatment, anti-depressants, anxiolytics, anti-psychotics, or other drugs with significant psychotropic effects then dose must be stable for a minimum of 4 weeks prior to enrolment with no expected plans for dose adjustment during the trial period and to the end of the trial; doe adjustment will be allowed during the trial if clinically indicated and will be documented (if a change in medication with psychotropic effects is required, this decisions can be made by the treating physician (e.g., starting an anti-depressant in clinic) without consultation with the CI. The clinician should attempt to discuss this with the PI prior to prescribing unless it is an emergency, and the change must be documented in the patient’s concomitant medications electronic Case Report Form (eCRF)). 

6. Patients that lack capacity to consent will be included in the trial to ensure that the sample is representative of the population that is likely to benefit. Patients that lack capacity will be required to have a person/ professional legal representative who is able to give informed consent on the patient’s behalf.

7. Female patients who are yet to reach menopause must agree not to fall pregnant while taking IMP.

8. Patients with sufficient knowledge of the English language or support to understand the Participant Information Sheet and complete the trial assessments. ​

Exclusion criteria

​1. Atypical clinical features or course that might suggest an alternative dementia diagnosis.

2. Any clinically relevant concomitant disease that will affect ability to participate in the trial, including but not limited to, chronic renal disease stage 5; history or acute or chronic pancreatitis; epilepsy or former history of convulsions; patients with recent myocardial infarction (within last  6 months); uncompensated congestive heart failure (NYHA III-IV); or uncontrolled hypertension.

3. Patients with severe hepatic impairment based on known history and/or significant abnormalities identified in blood liver function tests (e.g., levels in LFTs that are 2 to 3 times higher than the upper limit of normal), which in the judgement of the local PI would exclude the patient from the trial.

4. Patients taking Memantine, Amantadine, Ketamine or Dextromethorphan.

5. Any neurological or major psychiatric diagnosis that may be contributing to cognitive impairment above and beyond that caused by the patient’s DLB/PDD.

6. Renally impaired patients with eGFR <35 mL/min/1.73 m2

7. Patients without a reliable caregiver/ informant.​

Targeted, end date and PI

EPUT: 12

30.11.24

PI: Dr Zuzana Walker 

Study Lead: Veera Ramphal

Summary

To determine the feasibility and acceptability of collecting and analysing blood samples, plus cognitive data relevant to dementia risk from three sources of Oxfordshire-based participants (and online researcher registers, cognitive disorders clinic and GP practices) to inform a larger study. Blood samples taken twice, 12 months apart at the John Radcliffe Hospital. During the study visit, the participant will also complete a questionnaire to provide feedback on the study visit and the invitation process. They will also be asked to complete cognitive tests online at 6-monthly intervals (3 tests in total).​​

Inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study or if assenting, then a consultee (nearest of kin or holder of Power of Attorney) is available to make a declaration.

2. Male or female, aged 50+.

3. Within travelling distance to the Oxford centre.

4. Cognitively health OR experiencing subjective or objective pre-dementia cognitive impairment (i.e., subjective memory impairment (SCI), or Mild Cognitive impairment (MCI)) or having a diagnosis of dementia.​

Exclusion criteria

​​1. Have difficult venous access.

2. Lack of access to PC or tablet connected to the internet.

3. Not fluent in English.

Targeted, end date and PI

EPUT: 30

15.11.24

PI: Dr Isa Lubuola 

Study Lead: Olasumbo Olejeme

Summary

Aims to address elusive early diagnosis, disease progression monitoring and efficiency of assessing treatment with a new non-invasive brain imaging technique, Neuromelanin Magnetic Resonance Imaging (NM-MRI) to investigate changes in the brain associated with Dementia with Lewy Bodies (DLB). To determine if NM-MRI can detect early changes in these brain areas in DLB patients, and comparing with healthy (“control”) patients. Also examine associations between NM-MRI signals and cognitive / motor symptoms and disease duration in DLB, plus longitudinally assessing changes in NM-MRI signals over time and their relationship to cognitive decline.

Inclusive criteria

​General inclusion criteria for all participants: 

1. Aged 55+. 

2. Both males and females. 

3. Have capacity to give informed consent to participate in the study. 

4. Have a sufficient grasp of English to allow standardised cognitive testing. 

In addition to the general inclusion criteria, individuals in the DLB study group will: 

1. Fulfil the DLB consortium criteria. 

2. Have mild/moderate dementia, as participants with greater impairment than this are unlikely to be able to comply with study procedures. Degree of dementia will be determined according to MMSE score, which should be a minimum of 12/30. 

3. Have a reliable information (e.g., a spouse), who is well-known to the DLB participant and agrees to complete questionnaires for informant-related scales and provide background history. 

In addition to the general inclusion criteria, individuals in the control group will: 

1. Be ‘cognitively normal’, determined according to MMSE score, which should be a minimum of 26/30.

Exclusion criteria

1. Patients with concurrent psychiatric or neurological diseases (other than DLB), severe physical illnesses, or co-morbidities that may limit their ability to participate in the study fully should be excluded. 

2. Patients with a history of stroke (cerebrovascular accident) should be excluded. 

3. Patients with metallic implants that limit the safety or value of imaging should be excluded. 

4. Patients with any medical contraindication to MRI, including an inability to lie flat in the scanner for 60 minutes, should be excluded. 

Targeted, end date and PI

EPUT: 20

01.01.26 

PI: Dr Leonidas Chouliaras

Study Lead: TBC

Summary

Collect blood, saliva, urine and spinal fluid samples in those with MCI, Alzheimer’s and DLB, and healthy control volunteers. Explore immune changes, to what extent they differ, their impact on clinical symptoms and disease progression, and how they change over time.

Inclusion criteria

Either:

1. Diagnosis of:

     a) early Alzheimer’s disease (inc. MCI or mild AD dementia) or

     b) Lewy body disease (inc. MCI-Lewy body type or mild DLB) or

2. Cognitively normal for age and education within MMSE>26; and

3. Sufficient grasp of English language to permit meaningful cognitive testing.

Exclusion criteria

1. Severe dementia so as to be unable to complete with study procedures or MMSE<12.

2. Concurrent major psychiatric illness, severe physical illness or comorbidity that may limit ability to fully participate, inc. inflammatory medical conditions or taking immuno-suppressants (inc. oral steroids).

3. Absence of reliable informant (for patients).

4. Women who are pregnant or who are breastfeeding.

5. Severe impairment of vision or hearing that would make assessments difficult.

6. REM sleep behaviour disorder and/or late onset depression/ anxiety (healthy control group only)​

Targeted, end date and PI

EPUT: 40

01.10.26 

PI: Dr Leonidas Chouliaras 

Study Lead: Elizabeth Phillips

Summary

To recruit people from NHS memory clinics who would ordinarily undergo structural neuroimaging to have a high quality MRI scan with additional sequences and state-of-the-art analysis. The MRI data will be used to develop computational algorithms to assist with the diagnosis of dementia.

Inclusion criteria

​1. All people who attend participating clinics will be eligible to join the study if the treating clinician considers they need brain imaging.

Exclusion criteria

1. Participants will be excluded if they have contraindications to undergoing 3T MRI, such as a pacemaker.

Targeted, end date and PI

​​​31.03.25

PI: Dr Zuzana Walker

Study Lead: Kristine Haselup​