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Dementia clinical trials

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NCT ID: NCT04769024 Recruiting - Dementia Clinical Trials

Virtual Reality Intervention for the Reduction of Behavioral and Psychological Symptoms of Dementia

LUMEENCOMPAD
Start date: December 2, 2022
Phase: N/A
Study type: Interventional

Alzheimer's disease and related disorders (AD2) are characterised by cognitive changes and Behavioural and Psychological Symptoms of Dementia (BPSD). According to the French National Authority for Health (2009), Non-Pharmacological Interventions (N PhIs) are to be favo red in the treatment of BPSD. A few NPhIs have already shown their effectiveness in the management of these symptoms, such as music therapy or multi-sensory stimulation, but these techniques require trained staff and/or adapted premises. Over the past decade, innovative techniques have emerged in the field of NPhIs. Virtual Reality (VR) is one of them. Amongst the VR tools, the LUMEEN technology offers a suitable mediation tool for older adults with disabilities which allows to show immersive experiences in calm landscapes known to bring a feeling of well-being (beach, mountain, dolphins, classical music concert, animals in nature, etc.). The main objective of this study is to evaluate the effect of the LUMEEN Evasion module on the occurrence of BPSD in older adults living in residential aged care. Participants will be recruited in nursing homes and randomly assigned to the LUMEEN intervention group or the control group. Participants in the LUMEEN intervention group will attend 12 LUMEEN group session s in which they will be immersed for a few minutes in a selection of landscapes or scenes using virtual reality head-mounted displays and will then have a group discussion about the immersive experience they watched during the session. Participants in the control group will attend 12 non-digital (sensory, social, cognitive, creative) stimulation group sessions in which they will carry out typical pen-and-paper activities for this public which mainly stimulate language, immediate memory, semantic memory, and visual recognition (e.g., definitions, games of 7 differences, reconstruction of proverbs, quizzes…). The BPSD will be evaluated by the healthcare team before the start of the intervention and after the 12 sessions in both arms of the study (LUMEEN intervention and control) using the Neuropsychiatric Inventory filled out by the nursing staff (NPI). LUMEEN sessions are expected to reduce BPSD (especially apathy) more than control sessions. Thus, participants in the LUMEEN intervention group should have a greater difference between baseline and post-intervention NPI scores than the participants in the control group (in the direction of a reduction of the symptoms in the post-intervention evaluation). Secondary outcomes will also be measured focusing on apathy, well-being and social interactions. First of all, apathy will be evaluated thanks to the Apathy Inventory - Clinician before and after the interventions in both groups. Then, the state of well-being of the participant will be evaluated thanks to the EVIBE scale completed before and after each session. In addition, social interaction behaviors will be rated using the Social Behaviour Resident Index (SOBRI), collected through a 4-minutes participant observation during each session by an external observer. LUMEEN sessions are expected to improve these three outcomes more than control sessions. Differences are expected to be observed between the two groups : a) apathy should be lower after the sessions than before and the pre-post-intervention difference should be larger in the LUMEEN intervention group than in the control group; b) well-being should be (in average) higher after the sessions than before and the pre-post-intervention difference should be larger in the LUMEEN intervention group than in the control group ; and c) there should be, on average, more social interactions behaviours during the LUMEEN sessions than during the control sessions.

NCT ID: NCT04763941 Recruiting - Clinical trials for Clinical Dementia Rating (CDR) From the Analysis of Medical Record

Clinical Dementia Rating Medical Record

CLIMER
Start date: January 1, 2020
Phase:
Study type: Observational

The assessment of severity of the cognitive and functional impairment is essential in the follow-up of patients with neurocognitive disorders and in the assessment of the effectiveness of therapeutics. However, the systematic assessment of the Clinical Dementia Rating (CDR) scale is limited due to the time required to complete it (approximately 45 min to 1 hour). Insofar as studies have shown correspondences between the CDR and scales measuring cognitive and neuropsychological performance, and as part of memory consultations, several functional and neuropsychological scales are systematically administered, we wish to conduct a study validating the feasibility of the CDR based on information already available in the patient's file compared to the evaluation of the CDR by the usual method (face-to-face interview in consultation). This study should highlight the feasibility of scoring the CDR-SB from the files of patients in memory consultation, first in terms of reliability of the scores obtained compared to the standard evaluation, and on the other hand in terms of organization and duration of administration.

NCT ID: NCT04747431 Recruiting - Clinical trials for Frontotemporal Dementia

A Study of PBFT02 in Patients With Frontotemporal Dementia and Progranulin Mutations (FTD-GRN)

upliFT-D
Start date: September 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional copy of the GRN gene to the brain. This study will assess the safety, tolerability and efficacy of this treatment in patients with frontotemporal dementia and mutations in the progranulin gene (FTD-GRN).

NCT ID: NCT04743466 Recruiting - Depression Clinical Trials

Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes

Start date: February 13, 2020
Phase:
Study type: Observational

This study evaluates the association between testosterone levels and risk of dementia and adverse mental health outcomes (e.g. depression and anxiety). It is not known whether low testosterone levels may be associated with an increased risk of dementia. Learning about the association between testosterone levels and risk of dementia may help determine the long-term effects of androgen deprivation therapy and may help improve quality of life.

NCT ID: NCT04740567 Recruiting - Dementia Clinical Trials

Early Cognitive Intervention in Delirium

ECID
Start date: February 9, 2021
Phase: N/A
Study type: Interventional

This is a randomized control trial to determine if early cognitive training and rehabilitation improve 4-month cognition in hospitalized older (>=65 years old) delirious patients with and without Alzheimer's disease and related dementias. Enrolled patients will be randomized to receive cognitive intervention versus usual care at a 1:2 allocation ratio. Patients assigned to the cognitive intervention group will receive cognitive training daily during hospitalization and cognitive rehabilitation weekly for 12 weeks after hospital discharge. Patients will be evaluated for global cognition (primary outcome) and secondary outcomes at 4-months.

NCT ID: NCT04695743 Recruiting - Dementia Clinical Trials

Group CST Using Zoom: A Proof of Concept Study

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

People living with dementia (PLWD) often struggle to access services and treatment which may benefit their emotional and cognitive wellbeing, as well as disease progression. Transport provision; hospital access and restricted mobility are barriers that often deny people the opportunity to receive treatment in-line with NICE guidelines. Considering the current Covid-19 pandemic, hospital access and face-to-face treatment is even more limited at present; with services across the UK unable to offer their usual levels of care and support. This is particularly the case for people in vulnerable groups. Therefore, many services have been considering the potential of remote-access therapy, specifically the use of video-conferencing apps. During the covid-19 crisis and beyond, it is of urgent and practical need that we develop more accessible, innovative home-based group interventions to people with dementia that can be delivered remotely. A group at The University of Hong Kong, are undertaking a study entitled 'FaceCog' which involves the delivery of Cognitive Stimulation Therapy (CST) via the video-conferencing application 'Zoom'. CST is an established, evidence-based group intervention shown to improve quality of life and slow down cognitive deterioration in PLWD. In collaboration with the Hong Kong 'FaceCog' team, we propose to deliver a culturally adapted version of their Zoom-CST protocol in the UK in a proof of concept study during the current Covid-19 pandemic. The facecog Zoom-CST protocol is the first virtual CST protocol of its kind that we are aware of. It closely follows the original, evidence-based CST manual that was developed in the UK. It has been slightly adapted to make it useable on a virtual platform and to be culturally sensitive for use in Hong Kong. It incorporates all key elements and principles that have been evidenced to make the treatment effective. As we are delivering it in the UK, we will be using activities from the original manual, in place of the activities that have been adapted for the Hong Kong protocol. For example, we will use British phrases in the word games session rather than Chinese proverbs. Data on recruitment, attrition, attendance data, focus groups, participant-completed session feedback forms and qualitative post-session interviews, will offer us the opportunity to assess intervention acceptability. Outcomes related to cognition, quality of life and mood will allow us to make inferences about the potential for clinical impacts of such an intervention. Engagement analysis will allow us to explore the potential barriers and facilitators to virtual-delivered CST for this population and highlight any potential adaptations to intervention which may be needed. This project is intended as a preliminary exploration which will pave the way for future intervention-modifications and pilot-studies which can evaluate the potential benefits of 'virtually'-delivered CST. This research aims to: - Modify a pre-existing Zoom-CST protocol (FaceCog HK) to be culturally relevant and deliverable remotely within the UK. - Modify and develop resources for the groups, along with dementia-friendly 'how to' guides on using the chosen video-conferencing application. - Consult with stakeholders (including staff working within dementia care - clinical staff, charity organisations, and PLWD and their carers) about the potential foreseen barriers and facilitators to successful implementation of virtual-CST. Two remote, 'virtual' focus groups are proposed, one for professionals, and one for PLWD and/or informal carers. - Asses virtual CST's feasibility as guided by Orsmond and Cohn's (2015) discussion article on this topic, which identifies objectives of feasibility studies as, an evaluation of recruitment capability and sample characteristics, data collection procedures and outcome measures, the acceptability and suitability of the intervention and study procedures, the resources and ability to manage and implement the study and intervention, participants' responses to the intervention.

NCT ID: NCT04692441 Recruiting - Alzheimer Disease Clinical Trials

Apolipoprotein E (APOE) Genotype Effects on Triglycerides and Blood Flow in the Human Brain

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

High fat feeding (HFF) increases the risk of Alzheimer's disease (AD) but individuals who carry the AD risk gene E4 paradoxically improve after acute HFF. The investigators propose to further study this phenomenon with a clinical study to assess cerebral blood flow which can be measured by a technique called arterial spin labeling (ASL) on an MRI and is tightly related to brain metabolism.

NCT ID: NCT04680013 Recruiting - Dementia Clinical Trials

Genetic Studies in Familial Dementia

Start date: June 1, 2007
Phase:
Study type: Observational

The purpose of this study is to identify genetic factors that contribute to or cause dementia (loss of memory) and related disorders across all ages and ethnic groups. This includes a number of neurological diseases such as early and late-onset Alzheimer disease, mild cognitive impairment, and other dementias.

NCT ID: NCT04658654 Recruiting - Clinical trials for Mild Cognitive Impairment

Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients

ROMEMA
Start date: November 19, 2021
Phase: Phase 2
Study type: Interventional

The aim of the current project is to validate whether chronic intake (24 weeks) roflumilast (PDE4 inhibitor) can improve cognition in patients with (amnestic) mild cognitive impairment (MCI) and in patients with mild dementia. The project will demonstrate whether episodic memory, but also attention, information processing or executive function improves with chronic administration of roflumilast in (a)MCI and mild dementia patients.

NCT ID: NCT04639622 Recruiting - Clinical trials for Frontotemporal Dementia

GENetic Fronto Temporal Dementia Initiative in Lille

GENFI-LILLE
Start date: April 23, 2019
Phase: N/A
Study type: Interventional

GENFI Lille is a French cohort that belongs to the international initiative GENFI2, a five year longitudinal biomarker cohort study of genetic FTD and its associated disorders (including MND/ALS) investigating members of families with a known mutation in GRN or MAPT or an expansion in C9orf72 (including those affected with the disorder as well as at-risk members of families).