Alzheimer DiseaseDDENCT03900936
Detecting Dementia Earlier
An observational study of Alzheimer Disease and MCI, run by South Tees Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Aims 1. To determine whether the 4 Mountains test of allocentric (i.e. viewpoint-independent) spatial memory, and tests of memory for a recent experience (e.g. watching a brief video), to diagnose the early stages of Alzheimer's disease. 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, MCI, Aging
- What is being tested?
- Neuropsychological tests
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2017to 30 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with mild cognitive impairment (MCI) will be recruited from memory clinics from several different trusts, including NHS South Tees NHS FT and NHS Tees, Esk and Wear Valleys NHS FT. The diagnosis of MCI will be made by clinicians in accordance with the four core clinical criteria of Albert et al (2011). Briefly, these are: 1) Evidence of change (worsening) in cognition; 2) Impairment in one or more cognitive domains greater than expected for age/education; 3) Preservation of independence in functional abilities; 4) No current dementia.
Who may be able to join
- . MCI diagnosis.
Who cannot join
- 1. Presence of significant neurological condition such as Traumatic Brain Injury, Epilepsy, Stroke, Multiple Sclerosis, Brain tumour, Encephalitis, Meningitis, Parkinson's disease or visual impairment severe enough to hamper processing of visual test stimuli.
- 2. Major psychiatric disorder, such as schizophrenia, bipolar disorder and personality disorders such as borderline personality disorder. We will exclude severe (but not mild or moderate) clinical depression, and will exclude severe (but not mild or moderate) anxiety.
- 3. The use of cognitive enhancing drugs e.g. Cholinesterase inhibitors. 4. A history of alcohol excess or excess of illicit drug use within the last 5 years.
- (By definition, the diagnosis of dementia excludes a participant, since this would conflict with the fourth basis for the MCI diagnosis)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
South Tees Hospitals NHS FT
Middlesbrough, Teesside, TS4 3BW
Joe Millar, 1642854965, joe.millar@nhs.net
About this study
Official title: Detecting Dementia Earlier: Using Spatial & Episodic Memory Tests to More Accurately Predict Progression From Mild Cognitive Impairment to Alzheimer's Disease
Aims
- To determine whether the 4 Mountains test of allocentric (i.e. viewpoint-independent) spatial memory, and tests of memory for a recent experience (e.g. watching a brief video), to diagnose the early stages of Alzheimer's disease.
- We operationalise this as the ability of these tests to predict whether or not an individual progresses from having some cognitive difficulties (diagnosed as 'mild cognitive impairment' MCI) to subsequently developing Alzheimer's disease up to two years later.
- To assess whether the ability to diagnose early stages of Alzheimer's disease can be improved by combining the scores from different memory tests, from questionnaires assessing spatial and social aspects of everyday life.
- To assess whether scores on the spatial memory test are correlated with patients' reports of their everyday spatial memory, using a newly-developed questionnaire.
Read more
Outcome Measures
Primary study objective:
To determine the ability of allocentric spatial and episodic memory test performance to predict progression from mild cognitive impairment (MCI) to Alzheimer's disease.
Secondary outcome measure
- To assess to what extent social characteristics of everyday life may impact upon progression from mild cognitive impairment (MCI) to Alzheimer's disease.
- To correlate allocentric spatial test performance with real-world spatial ability as assessed through a novel spatial questionnaire.
Read the detailed description
In recent years, the need for tests that reliably diagnose the early stages of Alzheimer's disease (AD) with high accuracy has been strongly emphasised. Detecting AD in its earliest stages increases the likelihood that therapeutic agents (e.g. newly-developed drugs) and interventions (e.g. changes in diet and exercise) can prolong the period of high-quality, independent living and reduce the impact on patients, families and care providers. An ideal test would have the sensitivity to detect everyone who has early-stage AD, while simultaneously not giving a 'false alarm' to anyone who shows some age-related impairments in cognition but who does not have early-stage AD. Secondly, an ideal test should be free and simple to administer on a national scale, without requiring extensive training on the part of the testers to set up, run, and interpret. Unfortunately, currently used tests do not come close to this ideal. There are some good biomarker-based tests for early stages of AD, but they are costly, highly invasive and in effect impossible to use for national screening purposes. MRI imaging of brain regions affected early in AD detects early AD no better than neuropsychological testing and whilst it is non-invasive, many patients find it aversive. Here, we propose to examine whether the use of spatial and episodic memory tests can get us nearer to this ideal, whether used singly, together, or in combination with other tests.
The project has two stages. In stage 1, we will administer recently-developed spatial and episodic memory tests (along with more established neuropsychological tests) to patients who have recently been diagnosed with Mild Cognitive Impairment (MCI). At stage 2, clinical follow up (c.15-30 months after MCI diagnosis) we will establish those patients who have, and have not, progressed to AD. Analysis will then determine which tests at stage 1 best predicted progression-to-AD at stage 2.
- Conditions
- Alzheimer Disease, MCI, Aging
- Being tested
- Neuropsychological tests
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsDiagnostic test
This study is not an intervention as such. We are simply comparing the scores of MCI patients who subsequently went on to develop dementia vs those who did not.
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychological tests | This study is not an intervention as such. We are simply comparing the scores of MCI patients who subsequently went on to develop dementia vs those who did not. Receives: Diagnostic Test: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicting progression
To determine the ability of allocentric spatial and episodic memory test performance to predict progression from mild cognitive impairment (MCI) to Alzheimer's disease.
Measured: 3 years
Social Characteristics and questionnaires
- To assess to what extent social characteristics of everyday life may impact upon progression from mild cognitive impairment (MCI) to Alzheimer's disease.
- To correlate allocentric spatial test performance with real-world spatial ability as assessed through a novel spatial questionnaire.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start19 Jan 2017
- Primary completion20 Jun 2019 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Tees Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900936
- Sponsor's protocol ID
- 207985
- Acronym
- DDE
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be discussed with research team
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Dementia Earlier: Using Spatial & Episodic Memory Tests to More Accurately Predict Progression From Mild Cognitive Impairment to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03900936
- Acronym / sponsor ID
- DDE / 207985
- Conditions
- Alzheimer Disease, MCI, Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South Tees Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 20 Jun 2019 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 3 Apr 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.
Aims
- To determine whether the 4 Mountains test of allocentric (i.e. viewpoint-independent) spatial memory, and tests of memory for a recent experience (e.g. watching a brief video), to diagnose the early stages of Alzheimer's disease.
- We operationalise this as the ability of these tests to predict whether or not an individual progresses from having some cognitive difficulties (diagnosed as 'mild cognitive impairment' MCI) to subsequently developing Alzheimer's disease up to two years later.
- To assess whether the ability to diagnose early stages of Alzheimer's disease can be improved by combining the scores from different memory tests, from questionnaires assessing spatial and social aspects of everyday life.
- To assess whether scores on the spatial memory test are correlated with patients' reports of their everyday spatial memory, using a newly-developed questionnaire.
Outcome Measures
Primary study objective:
To determine the ability of allocentric spatial and episodic memory test performance to predict progression from mild cognitive impairment (MCI) to Alzheimer's disease.
Secondary outcome measure
- To assess to what extent social characteristics of everyday life may impact upon progression from mild cognitive impairment (MCI) to Alzheimer's disease.
- To correlate allocentric spatial test performance with real-world spatial ability as assessed through a novel spatial questionnaire.
Detailed description
In recent years, the need for tests that reliably diagnose the early stages of Alzheimer's disease (AD) with high accuracy has been strongly emphasised. Detecting AD in its earliest stages increases the likelihood that therapeutic agents (e.g. newly-developed drugs) and interventions (e.g. changes in diet and exercise) can prolong the period of high-quality, independent living and reduce the impact on patients, families and care providers. An ideal test would have the sensitivity to detect everyone who has early-stage AD, while simultaneously not giving a 'false alarm' to anyone who shows some age-related impairments in cognition but who does not have early-stage AD. Secondly, an ideal test should be free and simple to administer on a national scale, without requiring extensive training on the part of the testers to set up, run, and interpret. Unfortunately, currently used tests do not come close to this ideal. There are some good biomarker-based tests for early stages of AD, but they are costly, highly invasive and in effect impossible to use for national screening purposes. MRI imaging of brain regions affected early in AD detects early AD no better than neuropsychological testing and whilst it is non-invasive, many patients find it aversive. Here, we propose to examine whether the use of spatial and episodic memory tests can get us nearer to this ideal, whether used singly, together, or in combination with other tests.
The project has two stages. In stage 1, we will administer recently-developed spatial and episodic memory tests (along with more established neuropsychological tests) to patients who have recently been diagnosed with Mild Cognitive Impairment (MCI). At stage 2, clinical follow up (c.15-30 months after MCI diagnosis) we will establish those patients who have, and have not, progressed to AD. Analysis will then determine which tests at stage 1 best predicted progression-to-AD at stage 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological tests | – | Diagnostic Test: Neuropsychological testsThis study is not an intervention as such. We are simply comparing the scores of MCI patients who subsequently went on to develop dementia vs those who did not. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with mild cognitive impairment (MCI) will be recruited from memory clinics from several different trusts, including NHS South Tees NHS FT and NHS Tees, Esk and Wear Valleys NHS FT. The diagnosis of MCI will be made by clinicians in accordance with the four core clinical criteria of Albert et al (2011). Briefly, these are: 1) Evidence of change (worsening) in cognition; 2) Impairment in one or more cognitive domains greater than expected for age/education; 3) Preservation of independence in functional abilities; 4) No current dementia.
Key inclusion criteria (1 listed)
- . MCI diagnosis.
Key exclusion criteria (4 listed)
- 1. Presence of significant neurological condition such as Traumatic Brain Injury, Epilepsy, Stroke, Multiple Sclerosis, Brain tumour, Encephalitis, Meningitis, Parkinson's disease or visual impairment severe enough to hamper processing of visual test stimuli.
- 2. Major psychiatric disorder, such as schizophrenia, bipolar disorder and personality disorders such as borderline personality disorder. We will exclude severe (but not mild or moderate) clinical depression, and will exclude severe (but not mild or moderate) anxiety.
- 3. The use of cognitive enhancing drugs e.g. Cholinesterase inhibitors. 4. A history of alcohol excess or excess of illicit drug use within the last 5 years.
- (By definition, the diagnosis of dementia excludes a participant, since this would conflict with the fourth basis for the MCI diagnosis)
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 |
|---|---|---|
| Neuropsychological testsThis study is not an intervention as such. We are simply comparing the scores of MCI patients who subsequently went on to develop dementia vs those who did not. | Diagnostic test | Neuropsychological tests |
Primary outcome
Predicting progression
Time frame: 3 years
To determine the ability of allocentric spatial and episodic memory test performance to predict progression from mild cognitive impairment (MCI) to Alzheimer's disease.
Social Characteristics and questionnaires
Time frame: 3 years
1. To assess to what extent social characteristics of everyday life may impact upon progression from mild cognitive impairment (MCI) to Alzheimer's disease. 2. To correlate allocentric spatial test performance with real-world spatial ability as assessed through a novel spatial questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: Undecided. To be discussed with research team
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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.
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 MCI, run by South Tees Hospitals NHS Foundation Trust 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 1 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 3 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting progression (time frame: 3 years). 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?
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 3 Apr 2019.