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      Spore powder of Ganoderma lucidum for Alzheimer's disease : A protocol for systematic review

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          Abstract

          Background:

          Previous studies have reported that spore powder of Ganoderma lucidum (SPGL) may be effective for the treatment of Alzheimer's disease (AD). However, its efficacy is still inconclusive. Thus, this systematic review will aim to assess its efficacy and safety for AD.

          Methods:

          We will search the electronic databases of Cochrane Central Register of Controlled Trials, EMBASE, MEDILINE, the Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, and Chinese Biomedical Literature Database to assess the efficacy and safety of SPGL for patients with AD from their inceptions to the present. All case–control studies and randomized controlled trials will be considered for inclusion in this study. Two review authors will independently perform the study selection, data extraction, and risk of bias evaluation.

          Results:

          The primary outcome includes the cognitive status for patients. The secondary outcomes consist of the quality of life, AD symptoms, and adverse events.

          Conclusions:

          This systematic review will present the existing evidence for the efficacy and safety of SPGL for treating patients with AD.

          Dissemination and ethics:

          The results of this systematic review will be disseminated by through peer-reviewed journals. It does not needs ethic approval, because it does not involve individual patient data.

          Systematic review registration:

          PROSPERO CRD42019119426.

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          Most cited references13

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          Trial of Solanezumab for Mild Dementia Due to Alzheimer’s Disease

          Alzheimer's disease is characterized by amyloid-beta (Aβ) plaques and neurofibrillary tangles. The humanized monoclonal antibody solanezumab was designed to increase the clearance from the brain of soluble Aβ, peptides that may lead to toxic effects in the synapses and precede the deposition of fibrillary amyloid.
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            Randomized Trial of Verubecestat for Mild-to-Moderate Alzheimer’s Disease

            BACKGROUND Alzheimer’s disease is characterized by the deposition of amyloid-beta (A β ) plaques in the brain. A β is produced from the sequential cleavage of amyloid precursor protein by β -site amyloid precursor protein–cleaving enzyme 1 (BACE-1) followed by y-secretase. Verubecestat is an oral BACE-1 inhibitor that reduces the A β level in the cerebrospinal fluid of patients with Alzheimer’s disease. METHODS We conducted a randomized, double-blind, placebo-controlled, 78-week trial to evaluate verubecestat at doses of 12 mg and 40 mg per day, as compared with placebo, in patients who had a clinical diagnosis of mild-to-moderate Alzheimer’s disease. The coprimary outcomes were the change from baseline to week 78 in the score on the cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog; scores range from 0 to 70, with higher scores indicating worse dementia) and in the score on the Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory scale (ADCS-ADL; scores range from 0 to 78, with lower scores indicating worse function). RESULTS A total of 1958 patients underwent randomization; 653 were randomly assigned to receive verubecestat at a dose of 12 mg per day (the 12-mg group), 652 to receive verubecestat at a dose of 40 mg per day (the 40-mg group), and 653 to receive matching placebo. The trial was terminated early for futility 50 months after onset, which was within 5 months before its scheduled completion, and after enrollment of the planned 1958 patients was complete. The estimated mean change from baseline to week 78 in the ADAS-cog score was 7.9 in the 12-mg group, 8.0 in the 40-mg group, and 7.7 in the placebo group (P=0.63 for the comparison between the 12-mg group and the placebo group and P=0.46 for the comparison between the 40-mg group and the placebo group). The estimated mean change from baseline to week 78 in the ADCS-ADL score was −8.4 in the 12-mg group, −8.2 in the 40-mg group, and −8.9 in the placebo group (P=0.49 for the comparison between the 12-mg group and the placebo group and P=0.32 for the comparison between the 40-mg group and the placebo group). Adverse events, including rash, falls and injuries, sleep disturbance, suicidal ideation, weight loss, and hair-color change, were more common in the verubecestat groups than in the placebo group. CONCLUSIONS Verubecestat did not reduce cognitive or functional decline in patients with mild-to-moderate Alzheimer’s disease and was associated with treatment-related adverse events.(ClinicalTrials.gov [Related object:] .)
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              Alzheimer's disease: A review from the pathophysiology to diagnosis, new perspectives for pharmacological treatment

              Dementia is characterized by the impairment of cognition and behavior of people over 65 years. Alzheimer's disease (AD) is the most prevalent neurodegenerative disorder in the world, as approximately 47 million people are affected by this disease and the tendency is that this number will increase to 62% by 2030. Two microscopic features assist in the characterization of the disease, the amyloid plaques and neurofibrillary agglomerates. All these factors are responsible for the slow and gradual deterioration of memory that affect language, personality or cognitive control. For the AD diagnosis, neuropsychological tests are performed in different spheres of cognitive functions but since not all cognitive functions may be affected, cerebrospinal fluid biomarkers are used along with these tests. To date, cholinesterase inhibitors are used as treatment, they are the only drugs that have shown significant improvements in the cognitive functions of AD patients. Despite the proven effectiveness of cholinesterase inhibitors, an AD carrier, even while being treated, is continually subjected to progressive degeneration of the neuronal tissue. For this reason, other biochemical pathways associated with the pathophysiology of AD have been explored as alternatives to the treatment of this condition such as inhibition of β-secretase and glycogen synthase kinase-3β. The present study aims to conduct a review of the epidemiology, pathophysiology, symptoms, diagnosis and treatment of Alzheimer's disease, emphasizing the research and development of new therapeutic approaches.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                February 2019
                01 February 2019
                : 98
                : 5
                : e14382
                Affiliations
                [a ]First Ward of Neurology Department
                [b ]Second Ward of Neurology Department
                [c ]Department of Physical Diagnosis, First Affiliated Hospital of Jiamusi University
                [d ]Department of Pathophysiology, Jiamusi University School of Basic Medicine, Jiamusi, China.
                Author notes
                []Correspondence: Guo-Hui Wang, First Ward of Neurology Department, First Affiliated Hospital of Jiamusi University, No. 348 Dexiang Street, Xiangyang District, Jiamusi 154003, China (e-mail: wanggh19910@ 123456163.com ).
                Article
                MD-D-18-09460 14382
                10.1097/MD.0000000000014382
                6380698
                30702632
                d020bf7f-2c14-4042-a581-19d5eb13aa07
                Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 9 January 2019
                : 14 January 2019
                Categories
                3800
                Research Article
                Study Protocol Systematic Review
                Custom metadata
                TRUE

                alzheimer's disease,efficacy,safety,spore powder of ganoderma lucidum,systematic review

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