AMPER Proof of Concept Study

University of Strathclyde

Status: Not yet enrolling

Conditions: Alzheimer's Dementia (AD)

Treatments: Device: Personalised Agent-based Memory Prosthesis to Encourage Reminiscing (AMPER); Device: Non-Personalised Agent-based Memory Prosthesis to Encourage Reminiscing (AMPER)

Study type: Interventional

Funder types: Other

Identifiers

NCT06894953

341144

EP/V05564X/1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Personalised AMPER

Experimental group

Description:

AMPER app will be provided on a tablet, used with a caregiver in the participant's home for 12 weeks, at least twice a week AND the app will cater topic 'stories' (content) to the persons pre-stated preferences and provide content from the decades that correspond to the person's reminiscence 'bump' (when they were between 10 and 30 years old).

Treatment:

Device: Personalised Agent-based Memory Prosthesis to Encourage Reminiscing (AMPER)

Non-personalised AMPER

Active Comparator group

Description:

AMPER app will be provided on a tablet, used with a caregiver in the participant's home for 12 weeks, at least twice a week. AND the app will provide random content not linked to persons preferences or age.

Treatment:

Device: Non-Personalised Agent-based Memory Prosthesis to Encourage Reminiscing (AMPER)