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Neurocognitive Disorders clinical trials

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NCT ID: NCT05754567 Recruiting - Clinical trials for Neurocognitive Disorders

CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes

CONCEPTTKids
Start date: September 7, 2023
Phase:
Study type: Observational

Neurodevelopmental Outcomes among Offspring of women with Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial (CONCEPTT Kids International). An international, multicentre prospective cohort study of child and mother pairs. The potential number of recruits is 225 and the main inclusion criteria is child's mother who participated in the CONCEPTT Trial.

NCT ID: NCT05741853 Recruiting - Alzheimer Disease Clinical Trials

Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA. The overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how "strong" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.

NCT ID: NCT05738486 Recruiting - Dementia Clinical Trials

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Start date: February 28, 2023
Phase: Phase 3
Study type: Interventional

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

NCT ID: NCT05732519 Active, not recruiting - Alzheimer Disease Clinical Trials

Turkish Speech Analysis Development Study

TurkSpeech
Start date: March 1, 2023
Phase:
Study type: Observational

The aim of this observational study is to define speech alterations in the diagnosis of AD-related minor neurocognitive disorder (m-NBB) and major neurocognitive disorder (M-NBB). It is the development of a speech analysis method that can be used in future studies or routine clinical evaluations in these patients by using artificial intelligence and speech recognition methods that are planned to be developed based on the findings obtained. Purposes of the research 1. To define language disorders in the diagnosis of AD-related minor neurocognitive disorder (m-NBB) and major neurocognitive disorder (M-NBB). 2. Developing a speech analysis method that can be used in the early diagnosis of neurocognitive disorder patients by using artificial intelligence and speech recognition methods, which are planned to be developed based on the findings. 3. Evaluation of whether speech analysis distinguishes patients with m-NBB and M-NBB due to AD 4. Evaluation of whether speech analysis distinguishes minor NBD patients from healthy elderly patients. Standardized Mini-Mental Test, Clock Drawing Test, Montreal Cognitive Assessment Scale, Rey Auditory Verbal Learning Test, Verbal Fluency Test, Enhanced Cued Recall Test, Functional Activities Questionnaire, Trail Making Test, and Hamilton Depression Scale to evaluate the severity of depressive symptoms will be administered to the participants to assess cognitive functions. . In order to evaluate speech the Cookie Theft Picture Description Test, which is a part of the Boston Aphasia Test, will be administered to the participants.

NCT ID: NCT05732285 Recruiting - Multiple Sclerosis Clinical Trials

A Pilot Randomized Controlled Trial: CoINTEGRATE

CoINTEGRATE
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the feasibility of comprehensive multimodal individually tailored Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle sessions. The study team hypothesizes that combining evidence-based cognitive and affective therapies with lifestyle modifications is feasible and will improve the community integration (CI) and Quality of life (QoL) in patients with a neurocognitive disorder compared to usual care.

NCT ID: NCT05668598 Recruiting - Clinical trials for Neurocognitive Disorders

Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics

ECOTESTGER
Start date: March 8, 2023
Phase: N/A
Study type: Interventional

In this study the participants can be recruited via scheduled consultation and external institutions (associations, senior club..). Neuropsychological assessment will be realize to determine presence or absence of neurodegenerative disease. Study test is ecological MAI. This test are assigned in two groups (with or without neurocognitive disorders).

NCT ID: NCT05613491 Recruiting - Clinical trials for Postoperative Neurocognitive Disorders

Intranasal Insulin Improves Postoperative Neurocognitive Disorders in Elderly Patients

Start date: November 7, 2022
Phase: N/A
Study type: Interventional

Postoperative neurocognitive disorders (PND) are common postoperative complication of central nervous system, leading to increased risk of the working ability loss after surgery, longer hospital stay, increased medical costs and increased surgical mortality. It is classified as perioperative neurocognitive disorders in mental disorders.Aging is an important demographic characteristic in China, and the elderly is also a population susceptible to PND. There is a lack of targeted prevention and control measures for PND. Central insulin resistance is an important mechanism of cognitive impairment in elderly patients, and exogenous supply of central insulin may be an important measure to improve PND. Compared with conventional subcutaneous and intravenous supply, intranasal insulin administration not only has little effect on blood glucose and insulin levels, but also enters the center through the blood-brain barrier easily and efficiently. Long-term use of intranasal insulin can improve the cognitive function of chronic diseases, but there is a lack of clinical studies on improving PND by intranasal insulin. This study will verify the effectiveness of intranasal insulin in the PND improvement of elderly patients.

NCT ID: NCT05602467 Recruiting - Clinical trials for Mild Neurocognitive Disorder

Long Term Transcranial Pulse Stimulation (TPS) on Older Adults With Mild Neurocognitive Disorder (NCD)

Start date: November 25, 2022
Phase: N/A
Study type: Interventional

Background: Dementia, now known as major neurocognitive disorder (NCD), is a great health burden in Hong Kong and worldwide. In principle, to achieve its optimal benefits, intervention for dementia should begin at the earliest preclinical stage, which is defined as mild cognitive impairment (MCI). However, no evidence has been found to support a pharmacological approach to the prevention or postponement of cognitive decline during the stage of mild NCD. Non-invasive brain stimulation (NIBS) is increasingly recognized as a potential alternative to tackle this problem. The typical examples of NIBS are transcranial direct current stimulation (DCS) and transcranial magnetic stimulation (MS). Besides these, there is a new NIBS named transcranial pulse stimulation (TPS), which recently obtained CE marking in 2018 for the treatment of the central nervous system (CNS) in patients with mild to moderate Alzheimer's disease (AD). TPS is using repetitive single ultrashort pulses in the ultrasound frequency range to stimulate the brain. With a neuro-navigation device, TPS can achieve this in a highly focal and precisely targeted manner. TPS differs from DCS and TMS using direct or induced electric current. Instead, TPS provides good spatial precision and resolution to noninvasively modulate subcortical areas, despite the problem of skull attenuation. Using lower ultrasound frequencies TPS can successfully improve skull penetration in humans. TPS has shown its neuroprotective effects through inducing long term neuroplastic changes, supported by neuropsychological tests and neuroimaging investigations both in animal and human studies. Mild NCD is a golden period for intervention to avoid further progression to dementia. Although TPS has great potential as a new treatment option due to its neuroprotective effects, there is no TPS study done on mild CD subjects according to our knowledge. To determine the effectiveness of TPS in mild NCD, an open-label pilot study was conducted by our team from Dec 2020 to Dec 2021. The preliminary result was presented in the 2021 Brain Stimulation Conference and published in abstract format. We recruited 16 older adults who had mild CD. They received 6 sessions of TPS over 2 weeks. Assessments were done at the 3 time points. No subjects dropped out during the study. Statistically significant improvement was found in the primary outcome, HK-MoCA, from 18.06 to 20.25. The improvement was maintained till 12 weeks after the TPS intervention. No adverse effect was observed. The result suggested that TPS is likely to have an immediate effect on global cognition in mild CD, and the improvements were sustainable. However, a 2-week treatment duration may not be long enough to induce a significant change in neurodegenerative disease in long term. Up to date, there is no long-term NIBS treatment done on NCD. Therefore, we plan to conduct a pilot case-controlled trial to evaluate the efficacy of long-term TPS on cognition and brain structure in patients with mild ND based on the results of our pilot study. Objective: This study is to determine the efficacy of a 24-week program (32 sessions) of TPS in older adults with mild NCD. We hypothesized that TPS group is significantly more effective than control group in maintain or improve the global cognitive function measured by Hong Kong Chinese version of Montreal Cognitive Assessment (HK-MoCA) in patients with mild NCD. Design: This case-controlled trial will assess the efficacy of a 24-week TPS program on cognition and brain structure in subjects with mild NCD. All eligible participants will receive an intervention trial of TPS. They would receive 2 sets of stimulation programs, each set lasting 12-weeks. Participants would receive 3 sessions/week in the first 2 weeks and then 1 session/week in the subsequent 10 weeks. A total of 32 sessions (2 sets of 16 sessions) ofTPS will be delivered, with each session lasting 30 minutes. Data Analysis: The primary and secondary outcomes will be assessed at baseline, immediately after the 1st set of stimulation program (12th week), 2nd set of stimulation program (24th week), and 12 weeks after the intervention (36th week). The primary outcome will be the change of the Hong Kong Chinese version of the Montreal Cognitive Assessment (HK-MoCA). The secondary outcome includes specific cognitive domains, daily functioning, mood, and apathy. The intention-to-treat analysis would be carried out. Pre and post-intervention brain MRI scans will be used during the intervention to evaluate the changes in brain structure. A checklist of potential adverse effects associated with TPS administration will be generated from the available literature. Blood pressure and heart rate will be recorded at the beginning and at the end of the TPS intervention course.

NCT ID: NCT05597410 Recruiting - Alzheimer Disease Clinical Trials

Shanghai At Risk for Alzheimer's Disease: a Cohort Study

SHARAD
Start date: March 1, 2022
Phase:
Study type: Observational

The goal of this cohort study is to estimate the incidence of AD in the first-degree relatives of patients with AD. The main questions it aims to answer are: - cognitive changes of subjects at high risk of AD as ageing; - environmental and behavioral factors affecting AD incidence.

NCT ID: NCT05590845 Recruiting - Clinical trials for Anesthesia Complication

Evaluating Patient Knowledge About Perioperative Neurocognitive Disorders (KNOW-PND Study)

Start date: January 15, 2023
Phase:
Study type: Observational

Neurocognitive disorders remain one of the major perioperative complications. They are associated with delayed recovery, prolonged length of hospital stay and impacts on patients' quality of life. The incidence of PND ranges from 15-50%. While several causes have been investigated, PND seems to be due to the non-resolution of an inflammatory cascade, making some patients more at risk than others. As such, major risk factors include old age and lower education levels. As the global proportion of people aged 60 and above between 2015 and 2050 will increase from 12% to 22% and worldwide surgeries increases to >300 million procedures per annum the incidence of perioperative neurocognitive disorders with high morbidity and mortality will go up. In 2015, the American Society of Anesthesiologists (ASA) launched the 'Perioperative Brain Health Initiative' to increase awareness about perioperative neurocognitive disorders. (PND) While physicians seems to be more and more aware about this condition, data regarding patient awareness are not available. An observational, single-centre, cross-sectional survey study will be conducted in patients, 65 years and above undergoing elective total hip replacement surgery at AZ Sint-Jan (Brugge, Belgium) to assess patients' basic knowledge regarding PND.