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(३)Could spinal fluid test give early Alzheimer’s warning?

“A new Alzheimer’s detection test, which can diagnose the presence of the disease decades before symptoms appear, could be available to patients in just three years,” reports the Daily Express.

Sadly, this claim was not actually proven; what actually happened is that researchers developed a test that can detect low levels of an abnormal form of the protein amyloid beta. This protein accumulates in the brains of people with Alzheimer’s in the form of “plaques”.

Researchers tested 50 people diagnosed with probable Alzheimer’s disease, as well as 76 people with other brain conditions, for the abnormal protein.

They test was found to be effective. However, it is unclear how effective the test would be if used on people without dementia-like symptoms.

Due to the test’s invasive nature – which involved using a lumbar puncture, where a large needle is used to drain fluid out of your spine – it is highly unlikely that the results will lead to a screening programme for Alzheimer’s.

The researchers would like to use blood for their tests (as it is a simpler and more acceptable form of testing); however, it is unclear if this would work or be useful in medical practice.

Where did the story come from?

The study was carried out by researchers from the University of Texas Medical School and research centres in Italy. It was funded by the Alzheimer’s Association, CART Foundation, Mitchell Foundation, Italian Ministry of Health and MIUR.

One of the authors declared they were an inventor on several patents relating to the technique described in the study, as well as being the founder of Amprion Inc., a biotechnology company developing the technique for the diagnosis of neurodegenerative diseases.

The study was published in the peer-reviewed scientific journal Cell and has been made available on an open access basis, meaning it is free to read online.

The Daily Express’ claim that a new Alzheimer’s detection test that can “diagnose the presence of the disease decades before symptoms appear could be available to patients in just three years” is unsubstantiated. The test has only been used in people already given a probable diagnosis of Alzheimer’s.

While theoretically it may be possible to detect early changes before symptoms occur, this has not been tested or proven. The test also currently involves taking a sample of spinal fluid, and it is doubtful that such a procedure would be willingly carried out on individuals who had no symptoms of Alzheimer’s. With such a sketchy evidence base, it is safe to assume that most would not want a large hollow needle inserted into the base of their spine for a test.

What kind of research was this?

This was a diagnostic study looking at developing a new method for diagnosing Alzheimer’s using cerebrospinal fluid (CSF). Spinal fluid surrounds and supports the brain and spinal cord.

Alzheimer’s disease is the most common cause of dementia. Detecting dementia currently requires a person to present with symptoms of the condition, after which the person will usually have a range of physical and mental assessments. If other physical causes for these symptoms are ruled out, a diagnosis of probable dementia may be given.

However, doctors can only give a definite diagnosis by examining a person’s brain after their death, to look for the characteristic effects of Alzheimer’s on brain tissue.

These include the typical “amyloid plaques” which are made of deposits of the protein amyloid beta.

There is currently no cure for Alzheimer’s, and treatments may slow down the condition's progression, but cannot stop or reverse it.

One of the reasons may be that the brain has limited ability to repair itself, meaning that when symptoms are noticed, the damage cannot be reversed.

Researchers hope that if they find a way to detect the disease early, they could develop treatments to stop it progressing. The formation of abnormally large aggregates of amyloid beta in the brain is thought to start long before the onset of Alzheimer’s. If these formations could be detected, it could be an early sign of the illness.

What did the research involve?

The researchers wanted to see if they could develop a way of identifying people with Alzheimer’s by detecting abnormal (misfolded) amyloid beta in the spinal fluid.

The researchers were using a method they developed called protein misfolding cyclic ampliﬁcation (PMCA). This method makes use of the fact that even small amounts of abnormal forms of proteins like the amyloid beta protein can speed up the aggregation (clumping together) of the protein. Amyloid beta is mainly found in the brain, but some of it moves into the fluid surrounding the brain and spinal cord (CSF).

They first tested it in the lab to make sure their method could detect low levels of misfolded amyloid beta. They then analysed CSF from 50 people with Alzheimer’s, 37 people who had other degenerative brain diseases (including other forms of dementia) and 39 people who were affected by non-degenerative brain diseases, but had normal cognitive function. They were investigating whether they could tell these groups of people apart based on the test results. The researchers testing the samples did not know which samples belonged to which people, ensuring the results could not be interpreted in a biased way.

What were the basic results?

The researchers found that their PCMA technique was effective at detecting low levels of abnormal amyloid beta protein in laboratory tests.

The researchers also found their test performed differently on CSF fluid samples from individuals with Alzheimer’s, other degenerative brain diseases and those with normal cognitive function. The abnormal amyloid beta in spinal fluid from people with Alzheimer’s sped up the aggregation of more amyloid beta protein during the testing process.

Based on their results for age-matched Alzheimer’s and all of the control samples (people with other kinds of brain diseases):

the test correctly picked up 90% of people with Alzheimer’s – meaning that 10% of those with the disease would be missed (false negatives)
the test correctly identified 92% of those without the disease – meaning that 8% of people who did not have Alzheimer’s would test positive (false positives)
of those who tested positive, 88% did have Alzheimer’s (so about 1 in 10 people who tested positive would not in fact have the illness)
of those who tested negative, 93% did not have Alzheimer’s (so under 1 in 10 of people who tested negative would actually have the illness)

They say these results are better than those others have achieved by testing a different set of markers in spinal fluid.

The researchers note that these results were all from samples collected in three centres. Their technique did not work with samples collected at a fourth centre (they were “not amenable to assay”). They suspected that an aspect of the sample collection method may have affected their test, and they are looking into this further.

How did the researchers interpret the results?

The researchers concluded that their findings provide proof of principle for developing a highly sensitive and specific test for Alzheimer’s diagnosis.

Conclusion

The current research suggests it may be possible to identify those with Alzheimer’s using a biochemical test carried out on a spinal fluid sample. However, it is important to note that:

the development of this test is at a very early stage, and the study design used here is not ideal for assessing the test’s diagnostic accuracy. Population-based testing may follow, allowing researchers to better assess the accuracy and, more importantly, how many people could be given an incorrect diagnosis of dementia based on this test. However, development still needs to be done before population-based testing could be considered
it included samples from a small number of people diagnosed with different neurological conditions. The people in the trial with Alzheimer’s had not had post-mortem brain examinations, so their diagnosis was confirmed using just clinical testing
the researchers could not get the test to work on one set of samples. To be used in real life medical practice, it would have to be shown to reproducibly get good results
the proportion of the positive and negative tests that are correct is affected by the number of people being tested who actually have the illness. The test performed well on a set of samples where around a third of participants had Alzheimer’s. These results would be different if fewer people being tested had the illness, and the proportion of positive tests for people without the disease would be higher

There are also other questions surrounding how the test might be used and how useful it would be in medical practice. This test currently uses spinal fluid. To get this requires an invasive procedure involving placing a needle into the spine and can have side effects.

Doctors would not want to use a method like this unless they were fairly certain a person has Alzheimer’s, which essentially negates the usefulness of the current test.

This research should be regarded as a work in progress. It may lead to an effective blood test, which would be a lot more useful in screening people for Alzheimer’s disease; however, whether this becomes a reality is unclear.

(4)World Tuberculosis Day 2014: 3 challenges facing treatment of TB in India

March 24 is the World Tuberculosis Day

Tuberculosis is one of the early diseases that caught hold of the human race and still ranks in the top 10 infectious diseases known to kill humans. It affects about one-third of the world’s population and it can still be considered as a global emergency that needs to be addressed urgently. Despite the advances in healthcare and treatment strategies for tuberculosis, the situation is getting complicated every year with more and more people suffering from the disease. Today, on World Tuberculosis Day, we highlight 3 main reasons why tuberculosis is still a threat to India, with inputs from our experts Dr Kapil Salgia, a leading pulmonologist, and consultant physician Dr Pradip Shah, Fortis Hospital, Mulund.

Problem 1: Delayed diagnosis

Early diagnosis is an essential element to early control of the any infectious disease. In case of tuberculosis, the organism (Mycobacterium tuberculosis) causing the disease has the ability to remain latent in the infected person without causing active TB disease. Such patients are carriers of TB bacteria which can be transmitted to healthy individuals, thereby increasing the number of TB carries and active TB cases.

Dr Shah says, ‘With early diagnosis, TB can be contained and treated successfully. But routine clinical screening tests like X-ray and CT scan are not 100 percent effective in diagnosing TB, especially endobronchial TB. Hence for early diagnosis tests like bronchoalveolar lavage (BAL) ELISPOT should be encouraged.’

Dr Kapil Salgia says ‘Doctors should encourage microbiological testing of suspected TB patients. The sputum sample of patients should be sent for laboratory testing to identify if they are infected with multiple drug resistant TB (MDR TB). Additionally, if the patients are unable to produce sputum, they should be convinced to take up other diagnostic tests like bronchoscopy and fine needle aspiration’.

Problem 2: Patient non-compliance to TB treatment

Both the experts highlight the role of patient non compliance as a barrier to successful TB treatment. Dr Shah says ‘Minimum treatment period of TB disease is 6-9 months. However, patients who start feeling better within 2 months of taking drugs discontinue the treatment. This is one of the main pitfalls that we are facing in India.’

‘Once a TB patient stops taking the drugs, it gives an opportunity to TB bacteria to become resistant. Now these resistant bacilli that still present in the affected patients are transmitted through air which is inhaled by healthy individuals. This is how challenging cases of multiple drug resistant TB (MDR TB) are increasing,’ says Dr Salgia.

Problem 3: Lack of patient counseling

In India, a lot of people from rural areas suffer from TB. They don’t know the dangers of the disease and that they could be potent carriers of TB causing bacteria. Further people who diagnosed with TB don’t know the details like dosage, duration of treatment etc. ‘Patient counselling regarding detailed diagnosis, treatment compliance, right dosage and adequate treatment period and regular follow up is important if challenges in TB are to overcome,’ says Dr Salgia.

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The truth about tuberculosis

Much has been said and shown about tuberculosis (TB) with several films having shown people constantly coughing and being diagnosed with the condition. It is preventable and treatable, yet the condition of tuberculosis ( TB) continues to be a major health threat, because of growing drug resistance and spiralling costs of treatment. That apart, fears and stigmas around the condition are abound. The TB scenario has only left doctors perplexed.

"India is a heavy TB burden country. In urban settings , the problem is more severe compared to rural settings as the rate of transmission is higher due to overcrowded spaces. Patients from lower socio- economic status cannot afford diagnostic tests and anti- tubercular drugs, thus are diagnosed later and continue to spread the disease. Also, improper medication (irregularities in taking medicines by the patients or incorrect treatment regimen by private medical practitioners), leads to emergence of drug- resistant TB strains. Thus, worsening the situation," says Dr BR Das, president, research and innovation, SRL Diagnostics.
Drug resistance: major threat
Rising drug incidence happens to be the biggest threat to TB control and cure.
Drug resistant TB happens when the bacteria develops resistance to the most commonly used drugs in the first line of treatment regimen, leading to multidrug- resistant TB ( MDR- TB) and in extreme cases, extensively drug resistant TB ( XDR TB), where the bacteria fail to respond to even second line drugs," says Dr Chandan Kedawat, internal medicine specialist, PSRI Hospital. The other problem is that of patients not sticking to their drug regimen. " They end up discontinuing it because they feel better within a few weeks whereas the medicines should be taken for six months," points out Dr Kedawat.
Poor drug regulation
TB control has also become a challenge because of poor drug regulation and spiralling treatment costs. " Poor drug regulation has fuelled drug resistant TB, along with lack of discipline when it comes to TB regimen. There is no accountability, when it comes to adhering to proper diagnostic and treatment rules," says Dr Swati Sharma, New Delhi based internal medicine specialist. According to experts, lack of drug regulation has made even basic treatment of drug- sensitive TB difficult to monitor. " There are so many different formulations of TB drugs sold across and absolutely no monitoring," adds Dr Sharma.
Irrational prescription and indiscriminate use of non- WHO recommended drug regimens has become a huge problem. " It is the patients who suffer the consequences of poor regulation of TB drug formulations in India. An increasing number of our patients are being diagnosed with drug resistant TB ( DR- TB). We encounter a spectrum of resistance patterns which range from mono- drugresistant TB all the way through to extensively drug- resistant TB ( XDR TB)," says Dr Simon Janes, medical coordinator, MÃ©decins Sans FrontiÃ¨res ( MSF) India.

Often misdiagnosed
One of the biggest problems in the TB landscape continues to be that of misdiagnosis, because symptoms of this condition are very much similar to several other conditions. " Common conditions which are misdiagnosed as TB include infections caused by bacteria, parasite and fungal affecting different organs can mimic TB and need to diagnosed accordingly. Some malignancy like lymphoma can also mimic TB," says Dr Homa Mansoor, TB referent, MSF India. It takes a couple of tests to rule in TB and rule out other similar chest infections. " Usually chronic coughs lasting longer than two weeks and high fever; and an abnormal x- ray are considered to be suggestive of TB. But these are not restricted to TB, and could also be suggestive of other chest infections like bronchiatasis," says Dr Das.

Hence other diagnostic tests need to be performed to consider initiating antitubercular treatment. There are also other conditions, symptoms of which are familiar to TB. " Conditions like amyloidosis and sarcoidosis, have symptoms similar to TB too. And often it is too before the correct diagnosis happens," says Dr Kedawat.

ay TB, and the first thing that might strike you is a cloudy chest X- ray. But there are several other forms of TB which affect other organs of the body like that of skin, intenstinal, lymph nodemusculoskeletal, central nervous system, gastrointestinal, skin, pericardial, among others.
Way forward
Apart from systemic policy changes, there is much that can be achieved by individual efforts, which are as simple as sticking to your medicine regimen beginning with the first line of treatment.
" It is important to follow proper guidelines, avoid using anti TB medication for any other purpose other then TB, stick to total duration of care as treatment being of longer duration there is the tendency to default which leads to treatment failure and building up of resistance," says Dr Mansoor.
While most of us are exposed to TB during our lifetime, those with low immunity are more likely to contract it. So one of the ways to keep it off you and combat this condition when it strikes, is to build your immunity; gradually and naturally.