The adults with Down syndrome to develop a high risk of dementia; more than any other syndrome associated genetically with learning difficu...
The adults with Down syndrome to develop a high risk of dementia; more than any other syndrome associated genetically with learning difficulties.
Their sensitivity to the type of Alzheimer's disease is believed that the overproduction of the amyloid beta protein (A?) With respect to the basis of the localization of the precursor protein on chromosome 21, which is guided expressed in persons with Syndrome Down (trisomy 21) ,
, This specific genetic profile of people with Down syndrome, however, means that the results of studies on risk factors, prevention and treatment strategies in a population that is not applicable, can not have Down's syndrome and needs these factors in a study of evaluate people with down syndrome.
In this connection, a pilot study was recently released, has the following objectives:
- Evaluate approaches for the selection of participants;
- Collect data for the preparation of a study on a larger scale;
- Identify the best tools for the changes in cognitive function of assessment;
- Examine the use of? 40 and? 42 as a biomarker of cognitive impairment proteins.
The adults with Down syndrome to develop a high risk of dementia.
Methods
Adults who have been dropped over 50 years syndrome obtained by the Primary Care Network Scotland and Day Care in Scotland. Although researchers want to recruit 50 participants, recruitment was completed at the end of twelve months, with 21 participants randomized intervention (10 participants) or a control group (11 subjects).
Members of the intervention group received one tablet daily 40 mg of simvastatin, a statin that has already been shown, the risk of dementia in adults with Down syndrome to decrease, while those in the control group received a daily placebo pill. The intervention phase lasted 12 months, the researchers to evaluate a variety of evaluations with cognitive functions or cognitive impairment, and measured levels of A? 40 /? 42 at the beginning and at the end of the response.
In addition, 10 people were finished with Down syndrome and their caregivers qualitative interviews that examined their views on the participation in the study.
Results
Is a large-scale randomized controlled feasible?
During a year and the use of various recruitment strategies, 21 people with Down syndrome, they were randomized, of whom 13 completed the study. They were drawn from a population of more than 3 million people. Therefore, for a future clinical trial (ideally 160 participants), to recruit a sufficient number of participants should researchers use a total population of almost 24 million people. In other words, the study should cover almost half the population of the United Kingdom.
What tools can be used to control with Down syndrome in adult cognitive decline?
The difficulty with the appropriate measures cognitive impairment of choice is the possibility that people with disabilities with very poor results in most measures, leaving little space for the detection of other changes at the bottom of learning scale. Tests can be used to detect the changes in the working memory, and executive attention function over time is the memory for test objects communicate (the neuropsychological assessment of dementia in people with intellectual disabilities battery of test category) and flowing, cued recall test , and to a lesser extent, the revised test Tower of London and the selective lifting of the attention test. These cognitive tests were better suited for the detection of changes that measure adaptive behavior, quality of life and overall health.
Can we? 40 levels /? 42 as a biomarker?
All participants have to agree blood samples were taken, but the results show that the levels of A? 40 and? 42 were more stable in the blood for those who received simvastatin than for those who received a placebo. Furthermore cause Simvastatin has no side effects in this study.
As adults with Down syndrome and their caregivers feel in a randomized controlled trial to participate?
The interviews showed that people believe that the research is important, and that they felt well informed by the researchers. You encouraged to participate in the aid for the prevention of dementia in people with Down syndrome to feel were to identify effective strategies. However, most eligible participants were from participating in the study because of the need to take pills daily discouraged. Most of those who understood expressed the importance of randomization and accept as part of the study a positive experience.
Most eligible participants were discouraged from taking part because they do not want to take pills every day.
Strengths and weaknesses
This study, although it will be drawn to a small pilot study into consideration, is the first to try an experimental study of an intervention to cause cognitive disorders with dementia in people with Down's syndrome associated to prevent. the difficulties in research highlights with a clinical population is a challenge, not limited to people with learning difficulties, to determine with regard to the measures and the recruitment and retention strategies therein.
Without going as far as people with learning disabilities in all phases of the study, including a big step forward to participate actively with the (potential) participants and to help make their expectations and experiences in mind to train new research which it relates.
Summary
- Despite the high rate of incidence of dementia in people with Down syndrome and a high burden on the patient and caregiver, often ill-informed and aware of the risk
- The research in this area, by low recruitment rates and the limited availability of outcome measurement difficult if applicable obvious
- Although this pilot study suggests that simvastatin can be useful to reduce the occurrence of cognitive disorders in elderly people with Down syndrome to test large-scale controlled trial is not only desirable but also possible.
A large RCT of scale is possible, but will require a population coverage of 37% in the UK, the necessary 160 participants recruit.
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The main role
Cooper S, T Ademola, Catlike M, Douglas E, J Evans, Greenlaw N, C Haig Hassiotis A, A Jahoda, McConnachie A, J Morrison, ring H, J Starr, Stiles C, C Sirisena, F. Sullivan (2016 pilot randomized controlled trial :) to prevent the onset of cognitive impairment in adults with down (PT-COG study) syndrome. Tests, 17: 370th
