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Background The Ginkgo biloba special extract, EGb 761® has been widely used in the treatment of neuropsychiatric disorders, including Alzheimer’s disease (AD). Methods To guide clinical practice in the Asian region, the Asian Clinical Expert Group on Neurocognitive Disorders compiled evidence‐based consensus recommendations regarding the use of EGb 761® in neurocognitive disorders with/without cerebrovascular disease. Results Key randomized trials and robust meta‐analyses have demonstrated significant improvement in cognitive function, neuropsychiatric symptoms, activities of daily living (ADL) and quality of life with EGb 761®versus placebo in patients with mild‐to‐moderate dementia. In those with mild cognitive impairment (MCI), EGb 761® has also demonstrated significant symptomatic improvement versus placebo. World Federation of Societies of Biological Psychiatry guidelines list EGb 761® with the same strength of evidence as acetylcholinesterase inhibitors and N‐methyl‐D‐aspartate (NMDA) antagonists e.g. memantine (Grade 3 recommendation; Level B evidence). Only EGb 761® had Level B evidence in improving cognition, behaviour, and ADL in both AD and vascular dementia patients. Safety analyses show EGb 761® to have a positive risk‐benefit profile. While concerns have been raised regarding a possible increased bleeding risk, several randomized trials and two meta‐analyses have not supported this association. Conclusions The Expert Group foresee an important role for EGb 761®, used alone or as an add‐on therapy, in the treatment of MCI and dementias, particularly when patients do not derive benefit from acetylcholinesterase inhibitors or NMDA antagonists. EGb 761® should be used in alignment with local clinical practice guidelines.

Hearing loss (HL) usually indicates high risk of cognitive decline. We intend to investigate whether hearing aids fitting reduces cognitive decline of participants with hearing loss and mild cognitive impairment (MCI) by Chinese Hearing Solution for Improvement of Cognition in Elders-randomized controlled trial (CHOICE-RCT), a multicenter, parallel randomized controlled trial. We screened and enrolled participants aged above 60 years with moderate to severe sensorineural hearing loss and mild cognitive impairment from CHOICE project, outpatients in subcenters and high-risk population. After collection and quality control, the baseline data was stored in our platform called CRIP. In addition to baseline analysis, we will use statistical methods to explore correlations within it. Participant recruitment began from May 2021 to February 2024. We screened 20786 participants. 703 were enrolled finally with 408 from CHOICE Cohort, 230 from outpatients and 65 from high-risk population. Baseline characteristics: mean age was 74.52±7.15 years, 35.7% female; mean MMSE was 23.48±3.05. Enrolment of study has met the sample size. Follow-up data collecting is ongoing as planned, which will be completed at 2026.

AbstractObjectiveTo evaluate the feasibility and effectiveness of the CORDIAL program, a psychosocial intervention consisting of cognitive behavioral therapy (CBT), cognitive rehabilitation, and reminiscence to manage depressive symptoms for people with mild cognitive impairment (MCI) or dementia. DesignWe conducted a randomized controlled trial, based on a two-group (intervention and control), pre-/post-intervention design. SettingParticipants were recruited from five different old age psychiatry and memory clinics at outpatients’ hospitals. ParticipantsHundred and ninety-eight people with MCI or early-stage dementia were included. InterventionThe intervention group ( n = 100) received 11 individual weekly sessions of the CORDIAL program. This intervention includes elements from CBT, cognitive rehabilitation, and reminiscence therapy. The control group ( n = 98) received treatment-as-usual. MeasurementsWe assessed Montgomery–Åsberg Depression Rating Scale (MADRS) (main outcome), Neuropsychiatric Inventory Questionnaire, and Quality of Life in Alzheimer’s disease (secondary outcomes) over the course of 4 months and at a 10-month follow-up visit. ResultsA linear mixed model demonstrated that the depressive symptoms assessed by MADRS were significantly more reduced in the intervention groups as compared to the control group ( p < 0.001). The effect persisted for 6 months after the intervention. No significant differences between groups were found in neuropsychiatric symptoms or quality of life. ConclusionOur multicomponent intervention, which comprised 11 individual sessions of CBT, cognitive rehabilitation, and reminiscence therapy, reduced depressive symptoms in people with MCI and dementia.

The “very old intensive care patients” (abbreviated to VOPs; greater than 80 years old) are probably the fastest expanding subgroup of all intensive care unit (ICU) patients. Up until recently most ICU physicians have been reluctant to admit these VOPs. The general consensus was that there was little survival to gain and the incremental life expectancy of ICU admission was considered too small. Several publications have questioned this belief, but others have confirmed the poor long-term mortality rates in VOPs. More appropriate triage (resource limitation enforced decisions), admission decisions based on shared decision-making and improved prediction models are also needed for this particular patient group. Here, an expert panel proposes a research agenda for VOPs for the coming years.

This study explores the potential link between Alzheimer's disease (AD) and obesity by evaluating two oral drugs: NA-831 is a novel drug candidate with neuroprotective, neurogenic, and memory-enhancing properties for the treatment of Alzheimer's Disease (AD). NA-931, an analog of NA-831, targets IGF-1, GLP-1, and GIP pathways to treat obesity. NA-831 for Alzheimer's Disease: In a Phase 2 randomized clinical trial (ClinicalTrials.gov ID: NCT03538522), 112 participants with mild or moderate AD received either NA-831 or placebo. Patients with mild cognitive impairment (MCI) received 10 mg/day, while those with mild to moderate AD received 30 mg/day. Inclusion criteria followed NIA-AA standards, with MMSE scores ≥22 for MCI and 17-21 for mild to moderate AD. NA-931 for Obesity: A randomized, double-blind, placebo-controlled, dose-escalation, first-in-human study (ClinicalTrials.gov ID: NCT06615700) was conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NA-931. The study involved overweight/obese participants receiving single and multiple ascending doses, as well as multiple-dose administration in patients with Type 2 Diabetes Mellitus. NA-831 for AD: After 24 weeks, NA-831 treatment resulted in a significant cognitive improvement in AD patients, with a mean 4.1-point improvement on the ADAS-Cog-13 scale compared to placebo (p = 0.001). Additionally, 78% of patients demonstrated clinical improvement on the CIBIC-Plus scale (p = 0.01). NA-831 was well tolerated at 30 mg/day, with no serious adverse events reported. NA-931 for Obesity: NA-931 induced dose-dependent weight loss over 28 days. Participants receiving 150 mg/day lost up to 6.8% of body weight, representing a 5.1% greater reduction compared to placebo (p < 0.001). During the 8-week open-label extension, weight loss was sustained, with reductions reaching 12.7% (10.4% over placebo). NA-931 was well tolerated across all study phases. Mild nausea and diarrhea were each reported in 8.3% of participants at the highest dose (overall incidence: 3.7%). In the 12-week extension, nausea occurred in 16.6% and diarrhea in 8.3% of participants. No vomiting was observed. The clinical findings of NA-831 and NA-931 support a potential mechanistic link between Alzheimer's disease and metabolic disorders such as obesity and diabetes. While these results are encouraging, further studies are warranted to elucidate whether this association is causal.

Hearing loss is highly prevalent and can have significant consequences for older adults aging with cognitive impairment. Optimizing sensory function may be an important yet overlooked approach to reducing neuropsychiatric symptoms (NPS). Preliminary evidence supports the potential for hearing care interventions to reduce NPS. The Hearing health Equity through Research and Solutions (HEARS) intervention is a theory-driven hearing care intervention delivered by trained paraprofessionals using over-the-counter hearing technology, with demonstrated efficacy among older adults. Previously adapted for older adults with cognitive impairment, the HEARS-NPS intervention is a refined intervention aims to strengthen communication between care partners and participants with co-morbid hearing loss and cognitive impairment. The refined HEARS-NPS intervention will be evaluated through an NIA-funded NIA Stage 1b randomized controlled trial with a 6-week delayed treatment group in a cohort of 150 community-dwelling participants with cognitive impairment and hearing loss and their care partners. Dyads will be recruited in partnership with the Johns Hopkins Memory & Alzheimer's Treatment Center, the Johns Hopkins Alzheimer's Disease Research Center, and accompanying community outreach. The refined HEARS-NPS intervention will be delivered virtually by trained interventionists, older adults volunteers, and occur over two structured sessions that consist of 1) fitting and orientation to an OTC device and 2) targeted education and counseling on managing hearing loss in dementia. Outcomes will be assessed at baseline, 6-weeks, 3-months, and 6-months post-randomization. The HEARS-NPS trial seeks to explore the feasibility, acceptability, and preliminary efficacy of an affordable, accessible hearing care intervention as an accompanying non-pharmacological approach to NPS. The findings from this trial will not only inform best practices in managing NPS but may also be useful in the development of new, cost-effective non-pharmacological interventions for individuals with dementia and their care partners.

The increasing global direct and indirect cost of dementia care reached 1.33 trillion USD in 2020 with a projected rise to 9.12 trillion USD by 2050. Sleep disturbances are prevalent in People Living With Dementia (PLWD) and Mild Cognitive Impairment (MCI), impacting on daily living, increasing carer burden, and potentially accelerating disease progression. Effective sleep management could improve independence, reduce carer burden, and mitigate long-term economic costs. However, little is known about how to effectively manage sleep in PLWD/MCI within primary care settings. Challenges stem from a complex interplay of contributing patient and practice factors including inappropriate long-term hypnotic usage, diverse individual experience and perception of needs, and limited access to effective non-pharmacological interventions. Effective sleep management for PLWD/MCI might however be improved with tailored, person-centred, care plans with the input of family carers, that address individual needs and circumstances and promote independence. We co-designed a Tailored Intervention for Managing Sleep (TIMES) with Patient and Public Involvement (PPI) groups and health and social care professionals. TIMES aims to support General Practitioners and other primary care staff, e.g. nurses, pharmacists, to provide person-centred care for PLWD and MCI, by addressing the multifaceted aspects of sleep disturbance. In preparation for evaluating the effectiveness of TIMES in a subsequent, full-scale, randomised controlled trial, we conducted a cluster-randomized feasibility trial in 10 GP practices in England, targeting 64 patient-carer dyads, including economic analysis. We will present key findings from the feasibility trial, highlighting (i) barriers and enablers to successful recruitment and retention of both GP practices and patient-carer dyads; (ii) intervention fidelity and acceptability within the primary care setting; (iii) preliminary outcomes of the TIMES intervention on patient sleep, quality of life, carer burden, costs and resource utilisation including medication, and primary care staff confidence in managing sleep disturbances in PLWD/MCI. We will discuss the implications of our findings for improving sleep management for PLWD/MCI within primary care settings. Findings from this feasibility trial will inform the design and deployment of a subsequent full-scale randomized controlled trial of the TIMES intervention.

Although beta-amyloid (Aβ) and phosphorylated tau remain the preferred targets for disease-modifying treatments (DMT) against Alzheimer’s disease (AD), part of the pathophysiological mechanisms of cognitive impairment are related to neuroinflammation and oxidative stress. In mild cognitive impairment (MCI), a prodromal stage of AD and other neurodegenerative conditions, the joint appearance of inflammation, oxidative stress, and metabolic alterations are the common pathways of neurotoxicity and neurodegeneration. The standardized extract of Ginkgo biloba EGb 761 interferes with the pathogenic mechanisms involved in both the development of cognitive impairment due to AD and that of vascular origin. The primary objective of this study is to compare changes in the levels of blood markers of inflammation and oxidative stress after treatment with EGb 761 in a cohort of 100 patients with MCI. In addition, we aim to assess changes in these blood markers during an additional 12-month extension phase in which patients in the control group will also receive EGb 761 and patients in the active group will extend their treatment duration. Secondary objectives include comparing changes in neuropsychiatric and cognitive test scores between the baseline (v0) and 12-month visits (v2). This study is a Phase IV, single-center, randomized, open-label, parallel-group clinical trial consisting of the 12-month follow-up of a cohort of participants with MCI [Global Deterioration Scale (GDS) = 3] and an extension with an additional 12-month follow-up. During the first 12 months, participants will be randomized into two arms: in one arm, patients will receive 1 daily tablet of EGb 761 240 mg orally (study group, n  = 50), while in the other arm, patients will not receive EGb 761 and will undergo the same assessments as the treated group (control group, n  = 50). After the first 12 months of the study, patients in the EGb 761-treated group will continue treatment, and patients in the control group will be offered one EGb 761 240 mg tablet per day orally. All participants will be monitored for an additional 12 months. A battery of blood markers of inflammation and oxidative stress will be quantified at v0, v1, v2, v3, and v4. The Olink Proteomics panel of inflammation markers ( https://www.olink.com/products/inflammation/ ) will be used to evaluate 92 proteins associated with inflammatory diseases and related biological processes. The second panel measures 92 proteins involved in neurological processes. At v0, v2, and v4, neuropsychological and neurological evaluations will be conducted in addition to vital signs and anthropometric studies using a body composition monitor with bioimpedance technology (Tanita). Sixty percent of the 100 MCI patients recruited were women. The mean age was 73.1 years, and the mean time between symptom onset and MCI diagnosis was 2.9 years. The mean Mini-Mental State Examination (MMSE) score was 26.7. Depressive and anxiety disorders, as well as vascular risk factors, were the most frequent comorbidities among the cohort. The study is still ongoing, and results for the first year of treatment (v0, v1, v2) are expected by 2023. Individuals with MCI have an elevated risk of developing dementia. EGb 761 is used worldwide for the symptomatic treatment of cognitive disorders due to its neuroprotective effects. In experimental models and clinical observational studies, EGb 761 has shown strong antioxidant and anti-inflammatory activity. As a result, this study has been proposed to evaluate the antioxidant and anti-inflammatory effects on plasma markers and their potential clinical correlation with the progression of cognitive decline in patients with MCI. Trial registration: Registro Español de estudios clínicos (REec) number 2020-003776-41, ClinicalTrials.gov Identifier: NCT05594355.

As there is currently no pharmacological treatment for Parkinson's Disease Mild Cognitive Impairment (PD-MCI) with executive dysfunctions, specific cognitive interventions must be investigated. Most previous studies have tested bottom-up cognitive training programs but have not shown very good results. The aim of this study was to test ease of implementation, differential safety and preliminary efficacy of two top-down (strategy-learning) home-based, individualized, cognitive interventions: Goal Management Training (GMT), adapted for PD-MCI (Adapted-GMT), and a psychoeducation program combined with mindfulness exercises (PSYCH-Mind). This was a single-blind block-randomized between-group comparative study. Twelve PD-MCI with mild executive dysfunctions were divided in four blocks and randomly assigned to any of the two interventions. The participants were included if they had PD-MCI diagnosis (no dementia), with stabilized medication. Both groups (Adapted-GMT and PSYCH-mind) received five intervention sessions each lasting 60-90 minutes for five weeks. Measures were collected at baseline, mid-point, one-week, four-week and 12-week follow-ups. Executive functions were assessed with the Dysexecutive questionnaire (DEX) and the Zoo Map Test (ZMT). Quality of life (QoL) and psychiatric symptoms were also evaluated. Repeated measures ANCOVAs (mixed linear analysis) were applied to all outcomes. There was one drop out, and both interventions were feasible and acceptable. Despite the small sample size limiting statistical power, patients of both groups significantly improved executive functions per the DEX-patient (Time: F(4,36) = 2.96, p = 0.033, CI95%: 10.75-15.23) and DEX-caregiver scores (Time: F(4,36) = 6.02, p = 0.017, CI95%: 9.63-17.23). Both groups significantly made fewer errors between measurement times on the ZMT (Time: F(3,36) = 16.66, p = 0.001, CI95%: 1.07-2.93). However, QoL significantly increased only in PSYCH-Mind patients at four-week follow-up (interaction Time*Group: F(4,36) = 5.31, p = 0.002, CI95%: 15.33-25.61). Both interventions were easily implemented and proved to be safe. Because both interventions are arguably cost-effective, these pilot findings, although promising, need to be replicated in large samples. NCT04636541.

Background Up to 80% of breast cancer patients suffer from Cancer Related Cognitive Impairments (CRCI). Exercise is suggested as a potential supportive care option to reduce cognitive decline in cancer patients. This study will investigate the effects of a high-intensity interval endurance training (HIIT) on CRCI in breast cancer patients. Potentially underlying immunological and neurobiological mechanisms, as well as effects on patients’ self-perceived cognitive functioning and common cancer related side-effects, will be explored. Methods A single-blinded randomized controlled trial will be carried out. The impact of HIIT on CRCI will be compared to that of a placebo-intervention (supervised myofascial release training). Both interventions will be conducted simultaneously with the patients’ first-line chemotherapy treatment typically lasting 12–18 weeks. Fifty-nine women with breast cancer will be included in each of the two groups. The study is powered to detect (α = .05, β = .2) a medium effect size difference between the two groups (d = .5) in terms of patients’ change in cognitive testing performances, from baseline until the end of the exercise-intervention. The cognitive test battery, recommended by the International Cancer and Cognition Task Force to assess CRCI, will be used as primary measure. This includes the Hopkins Verbal Learning Test (learning/verbal memory), the Controlled Oral Word Association Test (verbal fluency) and the Trail-Making-Test A/B (attention/set-switching). The following endpoints will be assessed as secondary measures: Go-/No-Go test performance (response inhibition), self-perceived cognitive functioning, serum levels of pro- and antiinflammatory markers (tumor necrosis factor alpha, Interleukin-6, Interleukin-1 alpha, Interleukin-1 beta, C-reactive protein, Interleukin-1 receptor antagonist and Interleukin-10), serum levels of neurotrophic and growth factors (brain-derived neurotrophic factor, insulin-like growth factor 1 and vascular endothelial growth factor), as well as common cancer-related side effects (decrease in physical capacity, fatigue, anxiety and depression, sleep disturbances, quality of life and chemotherapy compliance). Discussion This study will provide data on the question whether HIIT is an effective supportive therapy that alleviates CRCI in breast cancer patients. Moreover, the present study will help shed light on the underlying mechanisms of potential CRCI improving effects of exercise in breast cancer patients. Trial registration DRKS.de, German Clinical Trials Register (DRKS), ID: DRKS00011390 , Registered on 17 January 2018.