ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia (Phase 2)

Launched by AUGMENTED EXPERIENCE E-HEALTH LABORATORY · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help manage the behavioral and psychological symptoms that can occur with Alzheimer's disease, using immersive technology. This means they are creating a special system that uses virtual reality or similar technology to see if it can effectively improve the well-being of patients with mild to moderate Alzheimer's. The researchers want to find out if this technology is safe, easy to use, and accepted by the patients.

To participate in this study, individuals need to be 60 years or older and diagnosed with mild to moderate Alzheimer's disease. They should also be able to walk with little assistance and have stable medication doses for their mood or mental health. The trial is currently recruiting participants, and those who take part can expect to engage with the immersive technology system and help the researchers understand if it could be a beneficial tool for managing symptoms of dementia. It’s important to know that some people, like those with certain cognitive impairments or serious health issues, may not be eligible to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 60 years old or older
• • Diagnosed with mild to moderate Alzheimer's dementia according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
• • Montreal Cognitive Assessment-Philippines (MOCA-P) score of 10-20 inclusive
• • Neuropsychiatric Inventory (NPI-12) score 1-50 inclusive
• • Reisberg Scale Stage 4-5 inclusive
• • Stable dose of antidepressants for the past 6 weeks
• • Stable dose of antipsychotics for the past 4 weeks
• • Able to walk unassisted or with minimal assistance, with or without assistive device
• • No other explanation for condition based on reasonable clinical diagnostics
• Exclusion Criteria:
• • Have mild cognitive impairment (no dementia)
• • Have MOCA-P score less than 10 or more than 20
• • Other non-amnestic dementia syndromes
• • Have receptive aphasia
• • Have significant visual or hearing impairment
• • Have an active psychiatric disorder prior to Alzheimer dementia diagnosis
• • Had previous episodes of seizures, diagnosis of epilepsy, or intake of antiepileptic or seizure medications
• • Have quadriplegia or paralysis of the dominant hand
• • Have a history of motion sickness
• • Experience claustrophobia
• • Have a diagnosis of a terminal illness or a life expectancy of less than one year