SET AND METHOD FOR SCREENING COGNITIVE IMPAIRMENT

Technical field

[0001] The present disclosure concerns a set, kit, for cognitive screening, independent of an individual's language and culture, able for assessing: memory, constructive capacity, executive functioning, processing speed and learning capacity.

Background

[0002] Currently, there is a marked demographic aging in most developed countries, accompanied by an increase in the frequency of chronic diseases, many of which are associated with cognitive impairments.

[0003] In Portugal, the aging rate was 128 elderly people for every 100 young people in 2011 and 144 elderly people for every 100 young people in 2015, which is expected to continue to increase in the coming years. This tendency reflects the reduction in infant mortality, the sharp drop in fertility and emigration, in addition to the increase in average life expectancy, as a result of improvements in the prevention and control of diseases that are the main causes of death. On the other hand, it translates into an increase in the prevalence of several diseases with increased risk at older ages, including important causes of mortality and morbidity, such as cardiovascular diseases, diabetes, strokes, musculoskeletal diseases, depression or dementia.

[0004] According to the World Health Organization (WHO), there were about 36.5 million people with dementia in 2010, and it is estimated that this figure could double every 20 years to 65.7 million in 2030 and 115, 4 million in 2050. In Portugal, based on international estimates, it is estimated that there are about 160,000 cases of dementia, 50 to 70% of which may correspond to Alzheimer's disease. However, studies that directly quantify the frequency and subtypes of dementia in the Portuguese population are scarce. Regarding the prevalence of mild cognitive impairment (MCI), considered as a prodromal stage of dementia, there is a single study on its prevalence in the northern part of the country [8, 9], in a sample of the population (between 55 and 79 years old) randomly selected from rural and urban areas, where a prevalence of 2.7% was observed for dementia and 12.3% for MCI.

[0005] Dementia is uncommon before age 60 (prevalence estimates range from 6.9% to 45.3%), but increases exponentially with age, doubling every five years after age 65, with age being one major risk factors.

[0006] Dementia is characterized by the presence of cognitive impairments in one or multiple domains (amnesia, aphasia, apraxia, agnosia, executive impairments) with a functional impact on activities of daily living. It also has a slow and progressive profile, whose evolution extends through the mild, moderate to severe phases.

[0007] Considering this information, it is important to highlight the role that psychological assessment plays in this context, with the need to implement specific and adequate tests to measure pre-morbid functioning and current functioning, depict possible changes arising from pathological processes and quantify the different domains in order to implement the most appropriate interventions.

[0008] The use of cognitive screening tests has been commonly suggested in international recommendations for signalling cognitive impairments associated with the development of neurodegenerative diseases. Neuropsychological assessment has been recommended as good practice, as a complementary diagnostic measure.

[0009] However, instruments allowing for the assessment of populations with low levels of education, as is still common, especially at older ages, are scarce. In Portugal, the regular education system currently includes compulsory schooling between 6 and 18 years of age, up to the 12 ^th year of schooling. However, in the age group above 65 years, a considerable percentage of illiterate and poorly educated people still persists, mainly due to social and political issues during the time they were of school age (e.g. poverty, difficulty in accessing school establishments). I n 2016, the percentage of people aged between 15 and 64 years with no education level was 2.1%. In the population over 65 years old, illiteracy stood at 25.7% and the proportion of people with little education, that is, having completed at least the primary education stage, was around 50%.

[0010] Thus, the development of effective cognitive screening instrument to respond to clinical and research needs in the current sociodemographic context is urgent. Among the features that are sought in a screening test, they can be listed: ease and speed of administration and quotation; good acceptance by the patient and the health professional who administers it; independence from aspects related to culture, language and education; good agreement between evaluators and good psychometric properties.

[0011] Currently, there are some standardized and validated screening instruments for the elderly Portuguese population. However, they often have limitations, such as the lack of normative data for illiterate people, the absence of a more heterogeneous stratification from the age of 65, great influence of education and language, little ecological validity and unsatisfactory psychometric properties.

[0012] The Mini Mental State Examination (MMSE) [3] is the most widely used and culturally adapted screening tool in several countries, being also the most studied. In 1998, the validation study of the MMSE for the Portuguese population showed cut-off points stratified according to schooling, namely 15, 22 and 27 points, for illiterate individuals, with schooling between one and 11 years or over 11 years, respectively. This test currently integrates new cut-off scores for illiterates and for schooling up to two years (22 points), ceasing to exist the division between illiterate and poorly educated as provided in the previous reference values. On the other hand, it has been verified that in older ages the performance in the MMSE has been worse. Despite this evidence, the cut off points are stratified, only according to schooling, given the great influence of education on the performance of the test. However, age can also have a significant effect on performance in the MMSE.

[0013] MMSE is sensitive to detect cognitive defects, but has low diagnostic accuracy (in hospital settings and primary health care) in the mildest forms of cognitive decline, such as MCL and mild dementia, leading to a high proportion of false negatives. On the other hand, in individuals with high schooling there is a ceiling effect. Its application has been suggested in complementarity with other screening tests, such as the Clock Drawing Test, the Verbal Fluency Test or even with questionnaires directed at the caregiver to increase the early detection of dementia and monitor cognitive changes.

[0014] The Montreal Cognitive Assessment (MoCA) [4] comprises tests that assess executive functions and has good sensitivity and specificity for detecting MCI and non-AD dementias. However, it is not applicable to illiterate people, being very dependent on education and language. In addition, the cut-off points are aggregated for the population over 65 years old. This is a methodological limitation, given that cognitive aging is not a homogeneous process. However, it has been considered as the most promising screening instrument, with several systematic studies. In Portugal, it is recommended for cognitive screening by the General Health Directorate [2].

[0015] The Clock Drawing Test (CDT) also has an influence on schooling and language, and is not applicable to illiterate people. In addition, the instruction itself, the quotation and interpretation of the results has been a challenge over the years, with several quotation systems, with Babins et al. (2008) presenting good internal consistency in relation to the rating systems of Rouleau et al., (1992) and Cahn et al., (1996). Despite assessing several cognitive domains, the Clock Drawing Test is a very useful screening instrument for detecting executive impairments in dementia. Its application has been suggested in complementarity with other tests, such as the MMSE, to increase diagnostic accuracy, since it has only enough discriminatory capacity to detect MCI.

[0016] Performance in the Addenbrooke- Revised version of Cognitive Assessment screening tests (Addenbrooke's Cognitive Examination-Revised; ACE-R) [5] and INECO Frontal Screening is also influenced by education and language. However, these tests do not consider normative data for illiterate people and the cut-off points of these instruments are also not stratified for the population over 65 years old.

[0017] Phonemic Verbal Fluency tests (words beginning with the letter "P") and Semantic Verbal Fluency tests (category of animals, food products, grocery and supermarket) have also been used as screening tests. Such instruments allow the assessment of non-motor processing speed, expressive language and executive functions, and the performance in these tests is influenced by age and education. Semantic Verbal Fluency integrates normative data for illiterate and poorly educated people, being an instrument with sensitivity, specificity and precision for detecting cognitive impairment.

[0018] It has been found that, in individuals with low schooling, tests that assess functional capacity for Instrumental Activities of Daily Living (lADLs) may be more effective in the early detection of cognitive impairments, compared to cognitive assessment tests. In the mild stages of dementia, the ability to perform lADLs is diminished and its performance is strongly related to cognitive functions, more specifically to executive functions. Global severity scales, such as the Clinical Dementia Rating (CDR) and the Global Deterioration Scale (GDS), allow an effective assessment of the progression of dementia and the effectiveness of certain treatments. The influence of some socio-cultural biases on these scales is small.

[0019] Document CN204516159U shows a cuboid object that can be used for cognitive screening, but has an assembly that is both more complex and less revealing of cognitive difficulties.

[0020] Bibliographic references

[0021] [1] Tolea, M. & Galvin, J. (2013). Current guidelines for dementia screening: shortcomings and recommended changes. Neurodegenerative Disease Management, 3(6), 565-573.

[0022] [2] Directorate-General for Health. Abordagem terapeutica das alteragdes cognitivas. Lisbon: Ministry of Health; 2011 [consulted 2014 Set 2] Available at: http://www.dgs.pt/?cr=21530.

[0023] [3] Folstein, M.; Folstein, S. & McHugh, P. (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.

[0024] [4] Nasreddine, Z. S., Phillips, N. A., Bedirian, V. et al (2005). The Montreal Cognitive Assessment (MoCA): A brief screening tool for Mild Cognitive Impairment. Journal of American Geriatric Society, 53(4), 695-699. [0025] [5] Mioshi, E., Dawson, K., Mitchell, J., Arnold, R., & Hodges, J. R. (2006). The Addenbrooke ^' s Cognitive Examination Revised (ACE-R): A brief cognitive test battery for dementia screening. International Journal of Geriatric Psychiatry, 21, 1078-1085.

[0026] These facts are described in order to illustrate the technical problem solved by the embodiments of this document.

General description

[0027] The present disclosure describes a Cube, initially conceived as CogwebART ^® cognitive training material for visuoconstructive abilities and later developed by a team of neurologists and neuropsychologists as a tool for cognitive screening.

[0028] In an embodiment of the present disclosure, the cube is a very brief screening instrument, which consists of fitting six pieces, in order to build a three-dimensional cube, within a maximum time of six minutes. It is an easy-to-apply test, which is thought to be little influenced by the effects of schooling (not a "paper and pencil" task), culture, language and easy to score. This test allows the analysis of various cognitive functions, such as visuospatial, visuoconstructive functions, executive functions (e.g. problem solving, cognitive flexibility, planning, spatial organization), manual dexterity, visual working memory, incidental learning and motor processing speed.

[0029] One of the advantages of the Cube is that it allows to screen the information processing speed, which according to Salthouse is one of the cognitive domains most influenced by the effects of age. This measure is useful and quite sensitive for the early assessment of cognitive impairment, there being currently few screening tests allowing its assessment. Phonemic and Semantic Verbal Fluency tests have also been used as screening tests, however, these assess the non-motor processing speed component, that is, the verbal processing speed. There are also tests such as the Trail Making Test (TMT), the WAIS-III Code subtest and the Stroop test that measure the speed of motor and visual processing, the speed of motor processing and incidental learning and the speed of perceptual processing, respectively; however, they are part of more comprehensive assessment strategies and are not screening instruments. On the other hand, the TMT part B is included in the MoCA screening test, in a more reduced form, but in this context, the total time of the test is not counted, limiting it as a processing speed screening test.

[0030] Thus the present disclosure stands out as a solution for short screening test, easy to apply and quote, allowing a greater standardization of the subjects' performance (reduction of the evaluator's bias, simple instructions). In addition, it can be a promising test in the detection of cognitive impairment, little influenced by the effects of schooling, language and culture, and can be applied in various contexts.

[0031] The present disclosure describes a test cube with application in several disease models, in order to verify psychometric properties.

[0032] The aging population requires rethinking the existing assessment methodologies for the elderly. In addition to meeting the requirements of this age group, screening instruments will have to present more disaggregated reference scores, according to age. Illiteracy and low education are still quite evident in the Portuguese context, so they should be taken into account when standardizing the instruments. The Cube stands out as a promising test in the evaluation of illiterate people, with poor education, with language impairment, hearing impairment, from different cultures and languages and with different ages. In addition, it will allow the assessment of the information processing speed.

[0033] The present disclosure aims to develop and validate a multicultural cognitive screening instrument, easy to quote and apply - a Cube suitable for psychometric testing, in studies involving participants from the general population and individuals with cognitive impairment of different etiology.

[0034] A set (4, 6) for screening a user's cognitive impairment is described, comprising 3 square faces (1) of equal dimensions to be fitted together by the user, forming half a cube, wherein each face has four sides (A, B), two sides of which with a first type of coupling (A) and two other sides of which with a second type of coupling (B), wherein two sides with the same type of coupling are located on opposite sides of the face, wherein each side (A, B) is configured to couple with a side with a different type of coupling than its own (B, A), and wherein each side (A, B) is also configured not to couple with one side with the same type of coupling (A, B) as its own.

[0035] In a preferred embodiment, the coupling can be a an interconnected fitting , wherein each side comprises one or more cubic protuberances (2) alternating with one or more cubic recesses (3) to fit, respectively, with the recesses (3) and protuberances (2) alternating on the other side.

[0036] In a preferred embodiment, the coupling can be a an interconnected fitting , wherein each side longitudinally comprises a plurality of alternating protuberances (2) and recesses (3) to fit, respectively, with the recesses (3) and protuberances (2) alternating on the other side.

[0037] In a preferred embodiment, the half cube comprises a common vertex formed by the 3 square faces when fitted together, and wherein said vertex is formed by three recesses with three sides with the first type of coupling and three protuberances (2) with three sides with the second type of coupling.

[0038] In a preferred embodiment, each side comprises a quadrangular prism-shaped recess at each end.

[0039] In a preferred embodiment, each face has symmetry in the direction between the two sides of the face with the first type of coupling (A).

[0040] In a preferred embodiment, each face has symmetry in the direction between the two sides of the face with the second type of coupling (B).

[0041] In a preferred embodiment, each face has symmetry in an interior-exterior direction of said half cube.

[0042] In a preferred embodiment, the coupling can be a hook and loop fastening coupling, one of the types of coupling being the hook and the other type of coupling being the loop.

[0043] In a preferred embodiment, the coupling can be a magnetic fixing coupling between a magnetic north pole and a south pole, one type of coupling being the south pole and the other type of coupling being the north pole. [0044] In a preferred embodiment, the square faces (1) can be manufactured with semi rigid material, in particular, cork, balsa wood, rubber and EVA foam, or combinations thereof.

[0045] In a preferred embodiment, two half cubes can be fitted to form the body of a cube.

[0046] An embodiment of said set for screening cognitive impairment may comprise 6 additional square faces of equal dimensions to be fitted together by the user, forming a cube, wherein each face has four sides, two sides of which with a first type of coupling and two other sides of which with a second type of coupling, wherein the two sides with the same type of coupling are located on opposite sides of the face, wherein each side is configured to couple with one side with a type of coupling different from its own, and wherein each side is also configured not to couple with a side with the same type of coupling as its own.

[0047] Also described is a method for operating the set for screening cognitive impairment that comprises the following steps: presenting a set of square faces (1) fitted together forming a cube or half cube; disassemble the cube or half cube, stack all the square faces (1) and indicate to the user that the cube or half cube must be assembled within a time limit; request that the cube or half cube be assembled as soon as possible, by fitting all the square faces (1) correctly; measure the time for building a first half cube and its respective vertex (4), and/or measure the time for building the cube, and/or count how many pieces are correctly fitted until the maximum time determined is reached.

Brief description of the figures

[0048] For easier understanding, figures are herein attached, which represent preferred embodiments that do not intend to limit the object of the present description.

[0049] Figure 1 - Illustration of an embodiment of a square face (1) of the half cube and its respective protuberances (2) and recesses (3) on each of its sides A and sides B.

[0050] Figure 2 - Illustration of a vertex view (4) of the half cube. [0051] Figure 3 - Illustration of an embodiment of an intersecting edge (5) of two square faces (1) of the half cube fitted together.

[0052] Figure 4 - Illustration of an embodiment of the half cube with 4 square faces (1) fitted.

[0053] Figure 5 - Illustration of an embodiment of the half cube with 5 square faces (1). [0054] Figure 6 - Illustration of the top view of the two fitted half cubes.

[0055] Figure 7 - Illustration of the base for cutting out the square faces.

[0056] Figure 8 - Illustration of cut square faces.

Detailed Description

[0057] The figures exemplify the main features of the present disclosure, namely that the cube comprises six identical, square sides.

[0058] In one embodiment, two fitted half cubes are presented to the participant in the final form and then disassembled in front of him, the 6 pieces are stacked on the table. Then the participant is asked to put the pieces back together to form two half cubes again. This is requested to be done as fast as possible, but fitting all parts correctly. Once the task has started, help or guidance should not be provided to the participant.

[0059] In one embodiment of the present disclosure, it will only be allowed up to six minutes for the construction of the two fitted half cubes.

[0060] In one embodiment, the following items are measured:

[0061] 1 - Time to build a vertex, that is, half a cube: the time is measured until at least three pieces are correctly positioned forming a vertex (a half cube).

[0062] 2 - Validation if the task was completed within 6 minutes: - The task is considered complete when the participant joins the six pieces together in order to form two fitted half cubes; - If the participant gives the task as completed and the two half cubes are close to their final shape, but having at most two small fitting errors, the task is accepted as complete and the final time is indicated, discounting one or two pieces in the number of pieces fitted correctly.

[0063] 3 - How many pieces were correctly fitted within the time limit: the number of pieces correctly fitted within the time limit is indicated, discounting one piece for each fitting error.

[0064] The half cube was applied to a group of individuals who live in Porto, Portugal. The time for the construction of the first vertex, that is, half a cube, the time for completion of two fitted half cubes and the number of correctly assembled parts were recorded. The Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) were also performed by an experienced assessor.

[0065] Results: We approached 972 individuals (60% women), with a mean age of 62.2 years (range 28-90; SD 12.6) and mean schooling of 10.0 years (SD 5.7). Only 6.5% of the participants refused or were unable to perform all tasks. The cube was correctly assembled by 88.7% of the individuals. Correct assembly was strongly associated with younger age and higher levels of education (p <0.001). The global average time for the first vertex was 48.3 seconds (SD 47.3s) and the average cube completion time was 102.2 seconds (SD 73.2s).

[0066] The time for building the first vertex and the time until the two half cubes are completed were significantly associated (Spearman correlation; p <0.001) with age, education level, MMSE and MoCA scores. Individuals with MoCA scores below the 2 cut off points of age/education adjusted for the Portuguese population were significantly slower (average 20.9 seconds) at completing the cube and had less correctly assembled parts than individuals above the cut-off points (fig. 2).

[0067] Conclusion: The half cube showed good usability in the population and the parameters of the half cube for screening cognitive impairment were significantly associated with validated cognitive assessment scales. Additional development and validation of the half cube for screening cognitive impairment has been carried out in clinical studies to assess its viability as a screening tool for the most prevalent neurodegenerative diseases.

[0068] The term "comprises" or "comprising" when used in this document is intended to indicate the presence of the features, elements, integers, steps and components mentioned, but does not preclude the presence or addition of one or more other features, elements, integers, steps and components, or groups thereof.

[0069] The embodiments described are combinable with each other. The present invention is not, of course, in any way restricted to the embodiments described in this document and a person with ordinary skills in the art may foresee many possibilities for modifying it and replacing technical features with equivalent ones, depending on the requirements of each situation, as defined in the appended claims.

[0070] Half cube in the context of the present document refers to the set of 3 equal square faces, joined together by the sides thereof at 90 ° angles, forming a vertex that belongs to the 3 faces. Therefore, each face is joined with the other two faces at an angle of 90 ° forming an edge common to two faces. The half cube therefore has 3 edges, each one being common to both faces.

[0071] The following claims define additional embodiments of the present description.