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Dementia Moderate clinical trials

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NCT ID: NCT06245031 Enrolling by invitation - Alzheimer Disease Clinical Trials

Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)

Start date: February 2024
Phase: N/A
Study type: Interventional

This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.

NCT ID: NCT06147479 Recruiting - Dementia Clinical Trials

Cognitive Stimulation in Daily Activities for People Living With Early to Middle Stage Dementia

CS-ADL
Start date: November 3, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to test the effect of CS-ADL is on people living with early to middle stage dementia. The main questions it aims to answer are: - What is the effect of CS-ADL on the ability of people with early to middle stage dementia to carry out their everyday activities? - What is the effect of CS-ADL on the memory, mood, communication, and quality of life of people living with early to middle stage dementia? Participants will take part in a group program that lasts 7 weeks, with one session per week, lasting two hours. Participants will take part in rewarding and stimulating activities, for example discussion, reminiscence, music, and practical activities such as baking, cooking, gardening. Participants will be asked to complete a variety of questionnaires before and after taking part in the group. Researchers will compare a group receiving CS-ADL to a group receiving their usual care, to explore whether CS-ADL works well in comparison to typical treatment provided by the health services.

NCT ID: NCT06125951 Recruiting - Alzheimer Disease Clinical Trials

Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease

XanaMIA
Start date: February 2024
Phase: Phase 2
Study type: Interventional

Xanamem® is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD). This XanaMIA Phase 2b study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion.

NCT ID: NCT05860127 Active, not recruiting - Dementia Clinical Trials

Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial

Start date: April 10, 2023
Phase: N/A
Study type: Interventional

Cognitive Stimulation Therapy (CST) is an evidence-based non-pharmacological group therapy shown to benefit people with mild to moderate dementia. Despite increasing availability of CST worldwide, access remains limited in the United States. This pilot pragmatic trial will embed CST referral into the standard care protocol of health care settings that serve people living with dementia in the state of Connecticut, and evaluate online delivery of CST known as virtual CST (V-CST), and assess the acceptability of V-CST to people living with dementia. The study design is a two-armed randomized embedded pragmatic clinical trial (ePCT). The trial aims to determine if cognitive decline is experienced less commonly among V-CST participants than control group members based on three widely used measures of cognition, the Montreal Cognitive Assessment (MoCA), St. Louis University Memory Screen (SLUMS), and Mini Mental State Exam (MMSE). The study population will be persons with mild to moderate dementia identified by clinicians in standard care. From this population, subject participants will be randomized to intervention and control groups. Patients randomly assigned to the intervention group will be referred by their clinical providers to participate in V-CST, and those who accept the referral will participate in the intervention.

NCT ID: NCT05637801 Recruiting - Alzheimer Disease Clinical Trials

A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)

Hope
Start date: December 13, 2022
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Approximately 530 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will be measured using the Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).

NCT ID: NCT05612711 Not yet recruiting - Behavioral Symptoms Clinical Trials

Dronabinol for Agitation in Dementia Crossover Trial

Start date: November 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to study the effects of dronabinol in US Veterans with agitation related to moderate to severe dementia. The main goals of the study are: - To evaluate the efficacy of dronabinol for the treatment of agitation in moderate to severe dementia compared to placebo - To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia compared to placebo Fifty (50) subjects will be given either dronabinol or placebo for 8 weeks. All subjects will then undergo a "washout" phase for 3 weeks, followed by the crossover intervention (i.e. subjects who received placebo during the first phase will receive dronabinol during the second phase, and vice versa). Thus, all participants will be taking dronabinol at some point during the study. During the study, subjects will undergo evaluations for: - Agitation - Cognitive changes - Physical changes (i.e. labs, ekg, physical exam)

NCT ID: NCT05343611 Recruiting - Dementia Clinical Trials

Chocolate and Physical Exercise to Reduce Malnutrition in Pre-dementia Aged People

Choko-AGE
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

We hypothesize that the antioxidant and cytoprotective functions of vitamin E combined with the cortisol-lowering effect of chocolate polyphenols and physical activity may help prevent the age-dependent decline of mitochondrial function and nutrient metabolism in skeletal muscle, key underpinning events in protein-energy malnutrition (PEM) and muscle wasting in the elderly. To test this hypothesis, a vitamin E functionalized dark chocolate rich in polyphenols will be developed with the collaboration of Nestlè Company, and its effects will be investigated combined with physical activity in a 6-month randomized case-control trial on pre-dementia elderly patients, a well-defined population of subjects at risk of undernutrition and frailty. Subjects stabilized on a protein-rich diet (0.9-1.0 g protein/Kg ideal body weight/day) and physical exercise program (High Intensity Interval Training specifically developed for these subjects), will be randomized in 3 groups (n = 34 each): controls (Group A) will maintain the baseline diet and cases will receive either 30 g/day of dark chocolate containing 500 mg total polyphenols (corresponding to 60 mg epicatechin) and 100 mg vitamin E (as RRR-alpha-tocopherol) (Group B) or the high polyphenol chocolate without additional vitamin E (Group C). Diet will be isocaloric and with the same intake of polyphenols and vitamin E in the 3 groups. Muscle mass will be the primary endpoint and other clinical endpoints will include neurocognitive status and previously identified biomolecular indices of frailty in pre-dementia patients. Muscle biopsies will be collected to assess myocyte contraction and mitochondrial metabolism. Laboratory endpoints will include the nutritional compliance to the proposed intervention (blood polyphenols and vitamin E status and metabolism), 24-h salivary cortisol, steroid hormones and IGF-1, and molecular indices of inflammation, oxidant stress, cell death and autophagy. These parameters will be investigated in muscle and blood cells by state-of-the-art omics techniques. Molecular and nutritional findings will also be confirmed in vitro using skeletal myotubes, blood leukocytes and neural cell lines. Clinical and laboratory results will be processed by a dedicated bioinformatics platform (developed with the external collaboration of the omics company Molecular Horizon Srl) to interpret the molecular response to the nutritional intervention and to personalize its application.

NCT ID: NCT05165186 Recruiting - Dementia Clinical Trials

Care Planning for a Loved One With Dementia: Knowledge, Preparing for Decisions, and Emotions

Start date: April 13, 2022
Phase: N/A
Study type: Interventional

The overall objective of this study is to compare knowledge, decisional conflict, preferences, and caregiver burden over time caregivers of Alzheimer's Disease and Related Dementias (ADRD) patients by comparing the effectiveness of a video decision aid intervention and enhanced usual care.

NCT ID: NCT05102201 Completed - Clinical trials for Cognitive Impairment

Effect of the Group-based Paro Intervention on Physiological and Psychological Outcomes

Start date: March 22, 2022
Phase: N/A
Study type: Interventional

This project contains three studies. This study will use a pilot randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations and mental well-being for specific attachment older adults with dementia. A randomized controlled trial, single-blind, two parallel groups, and repeated measures design were used to examine the effects of Paro intervention on neurobiologically changes and mental well-being for specific attachment older adults with dementia before, during, and after the intervention.

NCT ID: NCT04828434 Active, not recruiting - Dementia Clinical Trials

Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study

V-iCST
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Due to COVID-19, the routine treatment for dementia, Cognitive Stimulation Therapy (CST), is currently suspended in multiple countries. Access to treatment is, therefore, paramount. The investigators seek to bridge the current treatment gap with a virtual and individual form of CST, called Virtual Individual Cognitive Stimulation Therapy (V-iCST). This psychosocial intervention was adapted from the key principles of CST and developed within the Medical Research Council (MRC) framework for complex interventions. The investigators aim to evaluate the feasibility and acceptability of V-iCST in a Randomized Controlled Trial. This is a feasibility randomized controlled trial (RCT) for Virtual Individual Cognitive Stimulation Therapy (V-iCST), an evidence-based teletherapy for people with mild to moderate dementia. This psychosocial intervention is adapted from a routine and established dementia treatment, Cognitive Stimulation Therapy, and developed within the Medical Research Council (MRC) framework for complex interventions.