Clinical trial NCT03900936: Detecting Dementia Earlier
Official title: Detecting Dementia Earlier: Using Spatial & Episodic Memory Tests to More Accurately Predict Progression From Mild Cognitive Impairment to Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease
MCI
Aging
Lead sponsor: South Tees Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

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.

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.

Eligibility criteria: Inclusion Criteria:

* . MCI diagnosis.

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)

Primary outcomes:
measure: Predicting progression
timeFrame: 3 years
measure: Social Characteristics and questionnaires
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS FT
state: Teesside
Study officials:
References: