AMPER Proof of Concept Study

Официальное название

Proof of Concept Study of the Personalised AMPER System (Agent-based Memory Prosthesis to Encourage Reminiscing).

Обзор

The AMPER (Agent-based Memory Prosthesis to Encourage Reminiscing) system has been built to help people with Alzheimer's disease by improving their memory recall and quality of life. Alzheimer's often leads to the loss of autobiographical memories, which can affect a person's sense of identity. AMPER seeks to address this by creating a digital memory aid that uses an engaging, animated character on a tablet to help individuals with Alzheimer's reminisce about their past. By presenting personally relevant stories, images, audio, and videos, the character helps trigger memories and encourages interaction with caregivers. This is proof of concept study using a randomised controlled trial methodology. Twenty participants will be randomised to the control and 20 randomised to the intervention condition. The intervention group will use a personalised version of the AMPER app with tailored content and the control group will use a non-personalised version without specific adaptations. Over 12 weeks, participants will use the app at home with their caregivers. Researchers will measure changes in their memory and cognitive abilities before and after these 12 weeks. The primary goal is to see if personalised reminiscence improves the perceived quality of the reminiscence experience and autobiographical memory ability compared to the same app with a non-personalised approach. This will be measured using a combination of automatically gathered app use data and weekly caregiver feedback. Secondary goals are to investigate any difference between participants in the intervention and control condition in their technology acceptance, quality of life, self-esteem, everyday functioning and cognitive ability. Feedback from this research will help refine AMPER and inform future studies, with the ultimate goal of creating a widely accessible tool that supports memory and well-being in Alzheimer's patients. Table 1 provides a summary of the study.

Вмешательства

• Устройство Personalised Agent-based Memory Prosthesis to Encourage Reminiscing (AMPER)
  AMPER has an embodied agent (CGI character) who will ask questions about various memory cues such as pictures, audio files and videos from a BBC reminiscence archive (https://remarc.bbcrewind.co.uk/) to bring to the surface memories residing in the still viable regions of the brain. Personalised AMPER is personalised to preferences and age of the participant.
• Устройство Non-Personalised Agent-based Memory Prosthesis to Encourage Reminiscing (AMPER)
  AMPER has an embodied agent (CGI character) who will ask questions about various memory cues such as pictures, audio files and videos from a BBC reminiscence archive (https://remarc.bbcrewind.co.uk/) to bring to the surface memories residing in the still viable regions of the brain. Non-personliased AMPER is not personalised to preferences or age of the participant.

Первичные конечные точки

• Quality of autobiographical memory during AMPER use [Срок оценки: From enrollment to the end of AMPER use at 12 weeks]
• Autobiographical Memory ability (objectively rated) [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Autobiographical Memory ability (subjectively rated) [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Autobiographical Memory ability (subjectively rated on SAM) [Срок оценки: Baseline (week 1) and follow up (week 14)]

Вторичные конечные точки (10)

• Functional ability in tasks of everyday living [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Quality of life for the individual with Alzheimer's disease (subjective) [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Level of Depression experienced by the person with AD (subjective) [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Cognitive ability of the person with AD [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Verbal learning ability for the person with AD [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Short term verbal memory for person with AD [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Executive functioning for person with AD [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Modified Hachinski Ischemia Scale score for person with AD [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Self-esteem for the person with AD [Срок оценки: Baseline (week 1) and follow up (week 14)]
• Technology acceptance for person with AD [Срок оценки: Baseline (week 1) and follow up (week 14)]

Критерии участия

Критерии включения

\- Diagnosis of probable Alzheimer's disease of mild to moderate severity according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) and NINCS-ADRAD (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association) criteria.

• Age 50 or older
• Sensory (visual and auditory), language, and physical abilities adequate to perform assessments (corrective aids allowed).
• ACE III score between 20 and 82 (inclusive) (or equivalent score on MMSE (between 14 and 24, based on Law et al., 20123 equivalence data) or MOCHA (between 14 and 24 (based on Pendleberry et al., 2011 equivalence data).
• Having a caregiver or family member who can attend all visits, perform assessments, and supervise administration of study.

Критерии исключения

• Medical records indicate AD patients with the visual variant or having colour vision deficits.
• Medical records indicate a CT or MRI within 24 months prior to screening that indicates a diagnosis other than probable Alzheimer's disease.
• Medical records indicate any significant neurological disease other than probable AD (e.g. Parkinson's disease, Huntington's disease, brain tumor, normal pressure hydrocephalus, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of stroke, or history of head injury requiring hospitalization).
• On review of medical records, no clinically significant abnormal findings on previous physical examination, medical history, or clinical laboratory results that would indicate an alternative diagnosis.
• Current history of major psychiatric disorder (e.g. Major depression) (as indicated on medical records)
• History of substance misuse (as indicated on medical records).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Великобритания · 1 центр

• University of Strathclyde — Glasgow

Идентификаторы

NCT: NCT06894953 · 341144 · EP/V05564X/1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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