scholarly journals Efficiency of donepezil in elderly patients undergoing orthopaedic surgery due to underlying post-operative cognitive dysfunction: study protocol for a multicentre randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Huichen Zhu ◽  
Lu Cong ◽  
Yi Chen ◽  
Shaoyi Chen ◽  
Lingke Chen ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Elderly Patients ◽  
Cognitive Dysfunction ◽  
Orthopaedic Surgery ◽  
Controlled Trial ◽  
Acetylcholinesterase Inhibitor ◽  
Critical Role ◽  
Double Blind ◽  
Choline Acetyl Transferase ◽  
Link Type

Abstract Background Post-operative cognitive dysfunction (POCD) is an overarching term used to describe cognitive impairment identified in the preoperative or post-operative period. After surgical operations, older patients are particularly vulnerable to memory disturbances and other types of cognitive impairment. However, the pathogenesis of POCD remains unclear with no confirmed preventable or treatable strategy available. Our previous study demonstrated that the concentration of choline acetyl transferase in the cerebral spinal fluid was a predictive factor of POCD and that donepezil, which is an acetylcholinesterase inhibitor used in clinical settings for the treatment of Alzheimer’s disease, can prevent learning and memory impairment after anaesthesia/surgery in aged mice. This study aimed to determine the critical role of donepezil in preventing cognitive impairment in elderly patients undergoing orthopaedic surgery. Methods A multicentre, double-blind, placebo-controlled, crossover clinical trial will be performed to assess the efficacy of donepezil in elderly patients undergoing orthopaedic surgery. Participants (n = 360) will receive donepezil (5 mg once daily) or placebo from 1 day prior to surgery until 5 days after surgery. Neuropsychological tests will be measured at 1 day before the operation and 1 week, 1 month, 6 months and 1 year after the operation. Discussion This research project mainly aimed to study the effects of donepezil in elderly patients undergoing orthopaedic surgery due to underlying POCD and to investigate the underlying physiological and neurobiological mechanisms of these effects. The results may provide important implications for the development of effective interfering strategies, specifically regarding cognitive dysfunction therapy using drugs. Trial registration ClinicalTrials.govNCT04423276. Registered on 14 June 2020

Efficiency of Donepezil in Elderly Patients Undergoing Orthopaedic Surgery Due To Underlying Post-Operative cognitive Dysfunction: Study Protocol for A Multicentre Randomised Controlled Trial

2021 ◽  
Author(s):  
Huichen Zhu ◽  
Lu Cong ◽  
Yi Chen ◽  
Shaoyi Chen ◽  
Lingke Chen ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Elderly Patients ◽  
Cognitive Dysfunction ◽  
Orthopaedic Surgery ◽  
Controlled Trial ◽  
Acetylcholinesterase Inhibitor ◽  
Critical Role ◽  
Double Blind ◽  
Choline Acetyl Transferase ◽  
Randomised Controlled

Abstract Background Post-operative cognitive dysfunction (POCD) is an overarching term used to describe cognitive impairment identified in the preoperative or post-operative period. After surgical operations, older patients are particularly vulnerable to memory disturbances and other types of cognitive impairment. However, the pathogenesis of POCD remains unclear and no confirmed preventable or treatment strategy avilable. Our previous study demonstrated that the concentration of choline acetyl transferase in the cerebral spinal fliud was a predictive factor of POCD, and donepezil is an acetylcholinesterase inhibitor which was used in clinical for the treatment of alzheimer's disease can prevent the learning and memory impairment after anesthesia/surgery in aged mice. This study aimed to determine the critical role of donepezil in preventing cognitive impairment in elder patients undergoing orthopaedic surgery. Methods A multicentre, double-blind, placebo-controlled, crossover clinical trial will be performed to assess the efficacy of donepezil in elderly patients undergoing orthopaedic surgery. Participants (n = 360) will receive donepezil (5 mg once daily) or placebo from 1 day prior to surgery until 5 days after surgery. Neuropsychological tests will be measured at 1 day before the operation and 1 week, 1 month, 6 months and 1 year after the operation. Discussion This research project mainly aimed to study the effects of donepezil in elderly patients undergoing orthopaedic surgery due to underlying POCD and to investigate the underlying physiological and neurobiological mechanisms of these effects. The results may provide important implications for the development of effective interfering strategies, specifically regarding cognitive dysfunction therapy using drugs. Trial registration: ClinicalTrials.gov, NCT04423276. Registered on 14 June 2020.

scholarly journals Efficacy of Donepezil in Improving Cognitive Impairment Induced by Electroconvulsive Therapy in Patients with Mood Disorders: A Randomized, Double-blind, Placebo-Controlled Trial

2021 ◽  
Vol 15 (3) ◽  
Author(s):  
Elham Zarean ◽  
Morteza Sedehi ◽  
Yalda Heshmati
Keyword(s):  
Cognitive Impairment ◽  
Mood Disorder ◽  
Mood Disorders ◽  
Electroconvulsive Therapy ◽  
Controlled Trial ◽  
Acetylcholinesterase Inhibitor ◽  
Double Blind ◽  
Mini Mental Status Examination ◽  
Cognitive Disturbances ◽  
Addenbrooke’S Cognitive Examination

Background: Electroconvulsive therapy (ECT) is an effective strategy in the treatment of mood disorders; however, it is associated with some cognitive complications. Objectives: This study aimed to evaluate the efficacy of donepezil as an acetylcholinesterase inhibitor in improving cognitive impairment induced by ECT in mood disorder patients. Methods: Ninety-six mood disorder patients were randomly assigned to the donepezil (5mg/day) or placebo groups. The Persian versions of the Mini-Mental Status examination (MMSE) and Addenbrooke’s Cognitive Examination Revised (ACE-R) were used to evaluate cognitive performance before the first ECT session, after the fourth ECT session, and four weeks after the last ECT session. Results: The mean scores of MMSE and ACE-R revealed significant improvement in the donepezil group over time (P < 0.001). All ACE-R subscales increased significantly following the intervention implementation in the donepezil group (P < 0.001). Furthermore, the donepezil group reported no remarkable complications and completed the study. Conclusions: Donepezil co-administration with ECT may improve the ECT-induced cognitive disturbances.

scholarly journals Paraoxonase 1, B Vitamins Supplementation, and Mild Cognitive Impairment

2021 ◽  
pp. 1-19
Author(s):  
Joanna Perła-Kaján ◽  
Olga Włoczkowska ◽  
Anetta Zioła-Frankowska ◽  
Marcin Frankowski ◽  
A. David Smith ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Controlled Trial ◽  
Verbal Learning ◽  
Cognitive Status ◽  
B Vitamins ◽  
Paraoxonase 1 ◽  
Phenyl Acetate ◽  
Double Blind ◽  
Trail Making

Background: Identification of modifiable risk factors that affect cognitive decline is important for the development of preventive and treatment strategies. Status of paraoxonase 1 (PON1), a high-density lipoprotein-associated enzyme, may play a role in the development of neurological diseases, including Alzheimer’s disease. Objective: We tested a hypothesis that PON1 status predicts cognition in individuals with mild cognitive impairment (MCI). Methods: Individuals with MCI (n = 196, 76.8-years-old, 60% women) participating in a randomized, double-blind placebo-controlled trial (VITACOG) were assigned to receive a daily dose of folic acid (0.8 mg), vitamin B12 (0.5 mg) and B6 (20 mg) (n = 95) or placebo (n = 101) for 2 years. Cognition was analyzed by neuropsychological tests. Brain atrophy was quantified in a subset of participants (n = 168) by MRI. PON1 status, including PON1 Q192R genotype, was determined by quantifying enzymatic activity of PON1 using paraoxon and phenyl acetate as substrates. Results: In the placebo group, baseline phenylacetate hydrolase (PhAcase) activity of PON1 (but not paraoxonase activity or PON1 Q192R genotype) was significantly associated with global cognition (Mini-Mental State Examination, MMSE; Telephone Inventory for Cognitive Status-modified, TICS-m), verbal episodic memory (Hopkins Verbal Learning Test-revised: Total Recall, HVLT-TR; Delayed Recall, HVLT-DR), and attention/processing speed (Trail Making A and Symbol Digits Modalities Test, SDMT) at the end of study. In addition to PhAcase, baseline iron and triglycerides predicted MMSE, baseline fatty acids predicted SDMT, baseline anti-N-Hcy-protein autoantibodies predicted TICS-m, SDMT, Trail Making A, while BDNF V66M genotype predicted HVLT-TR and HVLT-DR scores at the end of study. B-vitamins abrogated associations of PON1 and other variables with cognition. Conclusion: PON1 is a new factor associated with impaired cognition that can be ameliorated by B-vitamins in individuals with MCI.

scholarly journals Effects of 12 Weeks Cosmos caudatus Supplement among Older Adults with Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 434
Author(s):  
Yee Xing You ◽  
Suzana Shahar ◽  
Nor Fadilah Rajab ◽  
Hasnah Haron ◽  
Hanis Mastura Yahya ◽  
...  
Keyword(s):  
Older Adults ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Controlled Trial ◽  
Mood Disturbance ◽  
Double Blind ◽  
Blood Biochemical ◽  
Cosmos Caudatus ◽  
Total Mood Disturbance ◽  
Biochemical Profiles

Cosmos caudatus (CC) contains high flavonoids and might be beneficial in neuroprotection. It has the potential to prevent neurodegenerative diseases. Therefore, we aimed to investigate the effects of 12 weeks of Cosmos caudatus supplement on cognitive function, mood status, blood biochemical profiles and biomarkers among older adults with mild cognitive impairment (MCI) through a double-blind, placebo-controlled trial. The subjects were randomized into CC supplement (n = 24) and placebo group (n = 24). Each of them consumed one capsule of CC supplement (250 mg of CC/capsule) or placebo (500 mg maltodextrin/capsule) twice daily for 12 weeks. Cognitive function and mood status were assessed at baseline, 6th week, and 12th week using validated neuropsychological tests. Blood biochemical profiles and biomarkers were measured at baseline and 12th week. Two-way mixed analysis of variance (ANOVA) analysis showed significant improvements in mini mental state examination (MMSE) (partial η2 = 0.150, p = 0.049), tension (partial η2 = 0.191, p = 0.018), total mood disturbance (partial η2 = 0.171, p = 0.028) and malondialdehyde (MDA) (partial η2 = 0.097, p = 0.047) following CC supplementation. In conclusion, 12 weeks CC supplementation potentially improved global cognition, tension, total mood disturbance, and oxidative stress among older adults with MCI. Larger sample size and longer period of intervention with incorporation of metabolomic approach should be conducted to further investigate the underlying mechanism of CC supplementation in neuroprotection.

Effects of Folic Acid Combined with DHA Supplementation on Cognitive Function and Amyloid-β-Related Biomarkers in Older Adults with Mild Cognitive Impairment by a Randomized, Double Blind, Placebo-Controlled Trial

2021 ◽  
pp. 1-13
Author(s):  
Dong Bai ◽  
Junting Fan ◽  
Mengyue Li ◽  
Cuixia Dong ◽  
Yiming Gao ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Folic Acid ◽  
Mild Cognitive Impairment ◽  
Cognitive Function ◽  
Digit Span ◽  
Controlled Trial ◽  
Amyloid Β ◽  
Amyloid Β Peptide ◽  
Double Blind ◽  
Full Scale Intelligence Quotient

Background: The neuroprotective benefits of combined folic acid and docosahexaenoic acid (DHA) on cognitive function in mild cognitive impairment (MCI) patients are suggested but unconfirmed. Objective: To explore the effects of 6-month folic acid + DHA on cognitive function in patients with MCI. Methods: Our randomized controlled trial (trial number ChiCTR-IOR-16008351) was conducted in Tianjin, China. We divided 160 MCI patients aged >  60 years into four regimen groups randomly: folic acid (0.8 mg/day) + DHA (800 mg/day), folic acid (0.8 mg/day), DHA (800 mg/day), and placebo, for 6 months. Cognitive function and blood amyloid-β peptide (Aβ) biomarker levels were measured at baseline and 6 months. Cognitive function was also measured at 12 months. Results: A total of 138 patients completed this trial. Folic acid improved the full-scale intelligence quotient (FSIQ), arithmetic, and picture complement scores; DHA improved the FSIQ, information, arithmetic, and digit span scores; folic acid + DHA improved the arithmetic (difference 1.67, 95% CI 1.02 to 2.31) and digital span (1.33, 0.24 to 2.43) scores compared to placebo. At 12 months, all scores declined in the intervention groups. Folic acid and folic acid + DHA increased blood folate (folic acid + DHA: 7.70, 3.81 to 11.59) and S-adenosylmethionine (23.93, 1.86 to 46.00) levels and reduced homocysteine levels (–6.51, –10.57 to –2.45) compared to placebo. DHA lower the Aβ40 levels (–40.57, –79.79 to –1.35) compared to placebo (p <  0.05), and folic acid + DHA reduced the Aβ42 (–95.59, –150.76 to –40.43) and Aβ40 levels (–45.75, –84.67 to –6.84) more than DHA (p <  0.05). Conclusion: Folic acid and DHA improve cognitive function and reduce blood Aβ production in MCI patients. Combination therapy may be more beneficial in reducing blood Aβ-related biomarkers.

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