Detecting Dementia Earlier
DDE
1 other identifier
observational
20
1 country
1
Brief 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.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.
- 3.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.
- 4.To assess whether scores on the spatial memory test are correlated with patients' reports of their everyday spatial memory, using a newly-developed questionnaire.
- 5.To assess to what extent social characteristics of everyday life may impact upon progression from mild cognitive impairment (MCI) to Alzheimer's disease.
- 6.To correlate allocentric spatial test performance with real-world spatial ability as assessed through a novel spatial questionnaire.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 19, 2017
CompletedFirst Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedApril 3, 2019
April 1, 2019
2.4 years
April 1, 2019
April 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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.
3 years
Social Characteristics and questionnaires
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.
3 years
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- MCI diagnosis.
You may not qualify if:
- \. 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.
- \. 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.
- \. 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Tees Hospitals NHS FT
Middlesbrough, Teesside, TS4 3BW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 3, 2019
Study Start
January 19, 2017
Primary Completion
June 20, 2019
Study Completion
August 30, 2021
Last Updated
April 3, 2019
Record last verified: 2019-04