The Behavioral Effects of Combination Therapy of Memantine and Acetylcholinesterase Inhibitors Compared with Acetylcholinesterase Inhibitors Alone in Patients with Moderate Alzheimer’s Dementia: A Double-Blind Randomized Placebo-Controlled Trial

Introduction:Identifying effective treatments is a critical issue for Alzheimer’s dementia (AD). The pathological amyloid deposits of AD result in disruption of the balance between long-term potentiation (LTP) and long-term depression (LTD) of neuronal cells and synaptic plasticity. Brain stimulation in dementia research, especially with relatively safe tDCS, has been taken seriously recently. In theory, tDCS affects long-term synaptic plasticity through LTP and LTD, thereby improving cognitive ability. Recently, an increasing number of studies have been conducted to evaluate the efficacy of tDCS in AD and concluded a positive therapeutic effect. Currently, there are no studies of tDCS for AD in Taiwan. In this study, we investigate the effects of tDCS in AD.Method:Using a double-blind, randomized and sham- controlled trial design, Sixteen AD aged 55-90 years (8 active, mean age 73.88 and 8 sham, mean age 74.75) were included in the study. AD diagnostics is according to DSM-5 criteria. The CDR ratings of AD participants ranged from 0.5 to 2. All subjects completed ten consecutive daily sessions in which they received either an active or a sham tDCS over the left dorsal lateral prefrontal cortex (anodal) and a cathodal electrode on the right supraorbital area. In each session, we applied a current intensity of 2 mA and an electrode size of 35 cm2 for 30 min in the active group. All subjects received a series of neuropsychological tests, which included CDR, MMSE, CASI and WCST, before and after these treatment sessions on the first day and 4 weeks later. Chi- square test, Wilcoxon signed ranks test and Mann-Whitney U test were used to assess the differences in participant demographic characteristics and to compare the differences among groups.Results:The active group showed significant improvement in total correct item, Conceptual level Responses (reflecting insight into the correct sorting principles), Categories Completed (reflecting overall success), and Trials to complete first categories (reflecting initial conceptual ability) of WCST 4 weeks later after the final stimulation. There were no statistically significant differences between before and after the 10-session course for the sham group.Conclusion:tDCS stimulation improves cognitive operation and Conceptual Ability of AD.

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Efficacy of Memantine for Agitation in Alzheimer’s Dementia: A Randomised Double-Blind Placebo Controlled Trial

PLoS ONE ◽

10.1371/journal.pone.0035185 ◽

2012 ◽

Vol 7 (5) ◽

pp. e35185 ◽

Cited By ~ 76

Author(s):

Chris Fox ◽

Monica Crugel ◽

Ian Maidment ◽

Bjorn Henrik Auestad ◽

Simon Coulton ◽

...

Keyword(s):

Controlled Trial ◽

Alzheimer’S Dementia ◽

Double Blind ◽

Alzheimer's Dementia ◽

Double Blind Placebo

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Cognitive improvement in mild to moderate Alzheimer's dementia after treatment with the acetylcholine precursor choline alfoscerate: A multicenter, double-blind, randomized, placebo-controlled trial

Clinical Therapeutics ◽

10.1016/s0149-2918(03)90023-3 ◽

2003 ◽

Vol 25 (1) ◽

pp. 178-193 ◽

Cited By ~ 72

Author(s):

M De Jesus Moreno Moreno

Keyword(s):

Controlled Trial ◽

Alzheimer’S Dementia ◽

Double Blind ◽

Alzheimer's Dementia ◽

Cognitive Improvement

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EGb 761® Does Not Affect Blood Coagulation and Bleeding Time in Patients with Probable Alzheimer’s Dementia—Secondary Analysis of a Randomized, Double-Blind Placebo-Controlled Trial

Healthcare ◽

10.3390/healthcare9121678 ◽

2021 ◽

Vol 9 (12) ◽

pp. 1678

Author(s):

Charlotte Kloft ◽

Robert Hoerr

Keyword(s):

Acetylsalicylic Acid ◽

Prothrombin Time ◽

Bleeding Time ◽

Controlled Trial ◽

International Normalized Ratio ◽

Alzheimer’S Dementia ◽

Egb 761 ◽

Double Blind ◽

Alzheimer's Dementia ◽

Double Blind Placebo

Following reports of bleeding upon Ginkgo intake, we assessed whether Ginkgo extract EGb 761® affects coagulation or platelet function or increases the risk of bleeding. In a double-blind, placebo-controlled trial, prothrombin time, activated partial thromboplastin time, international normalized ratio and bleeding time were measured in patients with Alzheimer’s dementia at baseline, weeks 6 and 26. A total of 513 patients were randomized to 120 mg (n = 169) or 240 mg EGb 761® (n = 170) or placebo (n = 174). No relevant changes were found for coagulation parameters and bleeding time. Numbers of bleeding-related adverse events were similar in all groups. Concomitant intake of acetylsalicylic acid was documented for 68 patients in the placebo group and 105 in the EGb 761® groups. Within these groups, the means at baseline and week 26 differed by less than 1 unit for prothrombin time and bleeding time and less than 0.1 unit for international normalized ratio. Data on warfarin treatment in nine patients each taking placebo or EGb 761® did not indicate enhancement of warfarin effects by EGb 761®. No evidence was found that EGb 761® affects hemostasis or increases the bleeding risk. No pharmacodynamic interactions with warfarin or acetylsalicylic acid were found.

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The Effects of Rasagiline on Glucose Metabolism and Cognition and Their Relationship to Tau Burden in a Double-Blind, Placebo-Controlled Phase Ii Clinical Trial of Participants with Alzheimer's Dementia

SSRN Electronic Journal ◽

10.2139/ssrn.3544838 ◽

2020 ◽

Author(s):

Dawn Matthews ◽

Aaron Ritter ◽

Ronald G. Thomas ◽

Randolph D. Andrews ◽

Ana S. Lukic ◽

...

Keyword(s):

Clinical Trial ◽

Glucose Metabolism ◽

Phase Ii ◽

Alzheimer’S Dementia ◽

Phase Ii Clinical Trial ◽

Double Blind ◽

Alzheimer's Dementia ◽

Double Blind Placebo

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Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

Pediatric Rheumatology ◽

10.1186/s12969-020-00488-9 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Ekaterina Alexeeva ◽

Gerd Horneff ◽

Tatyana Dvoryakovskaya ◽

Rina Denisova ◽

Irina Nikishina ◽

...

Keyword(s):

Combination Therapy ◽

Controlled Trial ◽

Randomized Study ◽

Primary Objective ◽

Disease State ◽

Inactive Disease ◽

Open Label ◽

Standard Regimen ◽

Double Blind ◽

Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

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