At the beginning of the study and at various points throughout, participants are usually asked to undergo various tests and examinations and to comply with various procedures. Some of these are paper-and-pencil tests or computerised tests, some involve filling out questionnaires or being monitored/observed. Others involve taking samples or undergoing procedures to detect biomarkers (measures of what is happening inside the living body). This includes blood and urine samples, cerebrospinal fluid (obtained by a lumbar puncture/spinal tap) and various brain scans. However, participants are under no legal obligation to have these tests, irrespective of any forms they may have signed, and they can withdraw from the study at any time (please see section on ethical issues).
In dementia research, cognitive tests, as well as tests to measure the ability to carry out daily tasks, are quite common. This is because researchers need to be able to measure the impact of a particular intervention. That could, for example, be a drug, the provision of a service or a lifestyle change, such as exercise, stopping smoking or adopting a healthy diet.
In this section, details are provided of some of the tests (sometimes called tools) that are commonly used by researchers. There are numerous tests and these are just a few examples of different kinds. It should be noted that tests are sometimes culturally biased which means that people from minority ethnic groups do not perform well on them. This is discriminatory and also means that the tools do not provide an accurate measure of everyone’s performance and hence lead to unreliable results for the study. For more information about the issue of cultural bias in testing materials, and examples of several assessment and diagnostic tests (some of which are used in research), please see Chapter 6 of our 2018 report on Intercultural care and support at: https://www.alzheimer-europe.org/resources/publications/2018-alzheimer-europe-report-development-intercultural-care-and-support
Alzheimer’s Disease Assessment Scale (ADAS) and Alzheimer’s Disease Assessment Scale - Cognition (ADAS-Cog)
The Alzheimer’s Disease Assessment Scale (ADAS) (Rosen et al. 1984) is a two-part scale designed to assess cognitive and non-cognitive symptoms of Alzheimer’s dementia. It is one of the most frequently used scales in clinical trials but is quite time-consuming (taking 40 to 45 minutes for a trained interviewer to administer).
The part which measures cognitive faculties is known as the ADAS-Cog. There are 7 performance items and 4 clinician-rated items coving memory, orientation, language and praxis. Possible scores range from 70 (severe impairment) to 0 (no impairment). The part which measures non-cognition contains 10 clinician-rated items covering agitation, depressed mood, psychosis (delusions and hallucinations), attention/concentration and changes in weight. It is not generally used for the assessment of people with severe dementia.
The Mini-Mental State Examination (MMSE) is a measure of cognitive function which was originally designed as a screening tool. It is perhaps the most widely used measure of cognitive function in the world and it is also used by researchers. It consists of 11 items designed to evaluate orientation, memory, attention, language and motor skills. Possible scores range from 30 (severe impairment) to 0 (no impairment). People with Alzheimer’s disease not receiving treatment tend to decline 2 to 4 points per year on the MMSE (Schneider, 2001). However, the MMSE is less sensitive to progressive decline in people who already have very low scores. A cut-off score of 23 for the presence of cognitive impairment has been suggested although this may vary slightly depending on the patient’s level of education (Burns et al., 2002). The MMSE is easy to administer and only takes about 5 to 10 minutes to complete.
The Montreal Cognitive Assessment was originally developed to help screen for mild cognitive impairment (MCI). It is easy and quick to administer (it takes about 10 minutes), and has been widely translated. t assesses attention/concentration, executive functions, conceptual thinking, memory, language, calculation and orientation. The maximum score is 30. A score of 25 or under indicates significant cognitive impairment. According to Sheehan (2012), it is particularly useful for people with vascular impairment, including vascular dementia.
The Activities of Daily Living Scale (ADL) was developed by Katz in 1963. It is used to assess the level of a person’s physical functioning and is generally considered an accurate measure. A person’s ability to accomplish a range of tasks without assistance is evaluated.
The six basic activities are:
4. transferring (i.e. getting in and out of bed or a chair),
5. continence and
Whilst they are very practical tasks, they all require a certain degree of cognitive functioning as tasks need to be planned, things organised, objects recognised and correctly used and choices made etc.
In 1969, Lawton and Brody designed the Instrumental Activities of Daily Living (IADL) Scale which was aimed at evaluating more complex activities of daily life. The patient’s capacity or incapacity to accomplish various tasks provides evaluators with a kind of proxy measure of that person’s cognitive abilities. Whilst the tasks seem very practical, they require a higher degree of cognitive functioning than those covered by the ADL scale.
They are divided into eight categories:
1. ability to use the telephone,
3. preparing food,
7. managing own medication and
8. ability to handle finances.
Within in each section, there are various activities for which points are attributed. For example, in the section on transportation a point is given for each of the following: travels independently on public transportation or drives own car; arranges own travel via taxi, but does not otherwise use public transportation; travels on public transportation when accompanied by another; but no points are gained for: travel limited to taxi or automobile with assistance of another; does not travel at all.
The Disability Assessment for Dementia (DAD) scale is designed to measure functional abilities related to basic and instrumental activities of daily living. It contains 40 items and takes about 20 minutes to complete.
The Neuropsychiatric Inventory (NPI) is a short test which is used to assess behavioural and neuropsychological disturbances in people with dementia. It measures a range of symptoms including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, aberrant motor activity, apathy, irritability, night-time behavioural disturbances and eating disturbances. The severity and frequency of symptoms are measured separately.
The Quality of Life in Alzheimer’s Disease Patient and Caregiver Report (QoL-AD) is used to assess quality of life and is based on reports provided by people with Alzheimer’s disease and their carers. The scale contains 13 items, each marked on a 4-point scale. The areas covered are mood, physical health, memory, relationships, self-esteem and current situation.
The Clinical Dementia Rating (CDR) is a global measure of dementia, which is usually completed by a clinician by means of an interview with the patient and the carer (which takes about 40 minutes). The clinician may already have gathered much of the information in the course of their previous contact with the patient.
The CDR provides a means to categorise people with dementia according to stages. A score of 0 would indicate no dementia and 0.5, questionable dementia, whereas a score of 1, 2 or 3 would be an indication of mild, moderate or severe dementia (Burns et al., 2002). Six areas are covered i.e. memory, orientation, judgement and problem-solving, community affairs, home and hobbies, and personal care.
Computerised Axial Tomography (often abbreviated to CT scan or CAT scan) is a type of scanning which allows researchers to detect shrinkage of the brain (which can also occur in people who do not have dementia). It can also serve to help differentiate between vascular dementia and Alzheimer’s disease. The scanning process involves taking pictures of slices of the brain by means of X-rays and a computer. A harmless dye may be injected to make the images clearer. The scanning takes about 15 to 30 minutes and is not painful or disturbing (i.e. no loud noises). However, the person needs to remain still during the process. For this reason, if a person is slightly agitated, he/she may be given a light sedative. (Source: Royal College of Psychiatrists, 2009).
Magnetic Resonance Imaging (MRI) is another type of scanning which takes pictures of the brain but not using X-rays. It provides more detail than CT scans and is also more expensive. MRI detects radio signals in the body which are produced in response to the effects of a powerful magnet contained in the scanner. The scanner is very noisy and whilst the whole process is painless, it may take up to an hour. It can be fairly uncomfortable to remain completely still for so long.
Single Photon Emission Computerised Tomography (SPECT) is a scan which measures blood flow in the brain. The patient is given an injection of a very mild, harmless radioactive substance (radionuclide) which travels in the blood to the brain. The pictures from the scan show slices of the brain and indicate the extent to which different parts of the brain have taken up the injected substance. This serves as a measure of how effectively blood is reaching different parts of the brain. The person has to sit still during the scanning procedure.
Positron emission tomography (PET) produces a three-dimensional picture of functional processes within the body (e.g. blood flow, oxygen use or glucose metabolism) using radionuclide as a tracer. The images obtained are usually reconstructed by means of a CT X-ray scan which is performed at the same time as the PET scan. The PET scan may use fluorodeoxyglucose (FDG) in order to measure regional glucose uptake. The tracer may be injected, swallowed or inhaled. After receiving it, the person may have to wait for about 30 to 60 minutes whilst the tracer travels through the body before the actual scanning (which takes 20 to 30 minutes) takes place (Source: Wikipedia, 2009 and www.radiologyinfo.org, 2009).