Study Underway For a New Drug to Reduce Alzheimer's Effect
From July 22nd to July 26th, 2018, the Alzheimer’s Association International Conference was held in Chicago, Illinois. Of the numerous presentations made during the Conference, one stood out as a possible medical breakthrough. According to NeuroActiva Inc., a company based out of California, research is being conducted on a drug called NA-831, which is aimed at reducing mild cognitive deterioration, associated with Alzheimer's disease.
The study was conducted by researchers of NeuroActiva Inc., in collaboration with the Florey Institute of Neuroscience and Mental Health in Australia, an affiliation of the University of Melbourne and Austin Hospital.
The Clinical Trial was carried out as a double-blind placebo-controlled study on the safety and efficacy of the drug NA 831. This essentially means that none out of the final 56 participants chosen (out of nearly 150 that enrolled to participate in the trial) had knowledge of whether they were receiving the placebo or the drug, and the distribution of the same was completely randomized.
Finally, the chosen 56 participants were randomly given either the placebo or 10 mg of NA-381, to be consumed strictly daily for a period of 24 weeks. According to Mr. Lloyd L. Tran, the Chairman and CEO of NeuroActiva Inc., the drug NA-831 was designed specifically to target neurotransmitters in the brain, with the aim of reconnecting them.
The first phase of the trial hoped that by revitalizing the communication system of the brain, both memory and functionality could be restored and improved. The main focus of the trial was reversing or lessening the effects of mild cognitive impairment (MCI), which is also defined as the “symptomatic pre-dementia stage” of the cognitive decline associated with Alzheimer’s. The first phase of the test, therefore, targeted specifically those with MCI rather than existing and prevalent dementia.
The Clinical Trial used two major scales to measure the outcomes of the study. These are :
1) Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) Score, which deals with 6 areas of cognitive function, namely memory, judgment and problem solving, orientation, home and hobbies, community affairs, and finally personal care.
2) Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL MCI), which made use of the Galasko method for the study, that covered 23 different areas of self-care, mental and physical functioning.
Both scales of each patient were determined in Week 2 and Week 24 respectively, after the required dosage of either NA-831 or the placebo was taken. The results were obtained through a series of interviews and activities directed at the concerned patient as well as their loved ones. Per the results of these interviews and activities, the outcome of each patient was noted down in a 5 point scale for CDR-SB and a scoring range of 0-78 for ADCS-ADL, depending on the level of impairment.
After comparing the scores of the scales collected in Week 2 and the scores collected in Week 24, it was determined that there were improvements in numerous existing symptoms of Alzheimer’s, including but not limited to fatigue, irritability, and rectified sleep patterns along with slowly improved cognitive functioning.
In the next steps of the trial, the dose of NA-831 taken by patients was increased to 20 mg and then 40 mg. It was found that up to 50 mg of the drug could be taken and easily tolerated on daily basis by patients, with little to no side effects, with only 4 patients complaining of minor headaches and diarrhea.
It has, however, been noted that the study did not comprehensively compare the results of the placebo and that of the drug NA-831, in a statistical manner. This makes it difficult to determine conclusively the effects of the drug on cognitive function in patients with either MCI or those suffering from moderate dementia, as a result of Alzheimer’s disease.
As the drug currently remains in the testing and trial phase, it has not been conclusively proven that NA-831 will prevent cognitive damage, nor has any health authority been in a capacity to approve manufacture or sale of the drug on a wide-scale. Nonetheless, NA-831 has opened new doors in medicine to approach Alzheimer’s treatments from a different and powerful perspective.
The study was conducted by researchers of NeuroActiva Inc., in collaboration with the Florey Institute of Neuroscience and Mental Health in Australia, an affiliation of the University of Melbourne and Austin Hospital.
The Clinical Trial was carried out as a double-blind placebo-controlled study on the safety and efficacy of the drug NA 831. This essentially means that none out of the final 56 participants chosen (out of nearly 150 that enrolled to participate in the trial) had knowledge of whether they were receiving the placebo or the drug, and the distribution of the same was completely randomized.
Finally, the chosen 56 participants were randomly given either the placebo or 10 mg of NA-381, to be consumed strictly daily for a period of 24 weeks. According to Mr. Lloyd L. Tran, the Chairman and CEO of NeuroActiva Inc., the drug NA-831 was designed specifically to target neurotransmitters in the brain, with the aim of reconnecting them.
The first phase of the trial hoped that by revitalizing the communication system of the brain, both memory and functionality could be restored and improved. The main focus of the trial was reversing or lessening the effects of mild cognitive impairment (MCI), which is also defined as the “symptomatic pre-dementia stage” of the cognitive decline associated with Alzheimer’s. The first phase of the test, therefore, targeted specifically those with MCI rather than existing and prevalent dementia.
The Clinical Trial used two major scales to measure the outcomes of the study. These are :
1) Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) Score, which deals with 6 areas of cognitive function, namely memory, judgment and problem solving, orientation, home and hobbies, community affairs, and finally personal care.
2) Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL MCI), which made use of the Galasko method for the study, that covered 23 different areas of self-care, mental and physical functioning.
Both scales of each patient were determined in Week 2 and Week 24 respectively, after the required dosage of either NA-831 or the placebo was taken. The results were obtained through a series of interviews and activities directed at the concerned patient as well as their loved ones. Per the results of these interviews and activities, the outcome of each patient was noted down in a 5 point scale for CDR-SB and a scoring range of 0-78 for ADCS-ADL, depending on the level of impairment.
After comparing the scores of the scales collected in Week 2 and the scores collected in Week 24, it was determined that there were improvements in numerous existing symptoms of Alzheimer’s, including but not limited to fatigue, irritability, and rectified sleep patterns along with slowly improved cognitive functioning.
In the next steps of the trial, the dose of NA-831 taken by patients was increased to 20 mg and then 40 mg. It was found that up to 50 mg of the drug could be taken and easily tolerated on daily basis by patients, with little to no side effects, with only 4 patients complaining of minor headaches and diarrhea.
It has, however, been noted that the study did not comprehensively compare the results of the placebo and that of the drug NA-831, in a statistical manner. This makes it difficult to determine conclusively the effects of the drug on cognitive function in patients with either MCI or those suffering from moderate dementia, as a result of Alzheimer’s disease.
As the drug currently remains in the testing and trial phase, it has not been conclusively proven that NA-831 will prevent cognitive damage, nor has any health authority been in a capacity to approve manufacture or sale of the drug on a wide-scale. Nonetheless, NA-831 has opened new doors in medicine to approach Alzheimer’s treatments from a different and powerful perspective.
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