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Aims
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological tests | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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)
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Tees Hospitals NHS FT | Recruiting | Middlesbrough | Teesside | TS4 3BW | United Kingdom |
To be discussed with research team
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |