AMPER Proof of Concept Study

NCT06894953 | Not Yet Recruiting

• 2 other identifiers: 341144EP/V05564X/1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Dementia (AD)

Keywords

Azheimer's disease; Dementia; Reminiscence; Reminiscence technology; Assistive technology; Intelligent Virtual Agent

Outcome Measures

Primary Outcomes (4)

• Quality of autobiographical memory during AMPER use

  We will analyse the richness of episodic and semantic details in the participant's recollections (which are audio recorded during the trial). This method will ensure a systematic evaluation of memory quality during interactions facilitated by the AMPER app. This rating procedure will use the methodology outlined by Levine and colleagues (2002) and will be scored using the semi-automated methodology outlined by Wardell and colleagues (2021).

  From enrollment to the end of AMPER use at 12 weeks

• Autobiographical Memory ability (objectively rated)

  Objective rating of Autobiographical Memory ability using the Autobiographical Memory Interview (Kopelman et al., 1989)

  Baseline (week 1) and follow up (week 14)

• Autobiographical Memory ability (subjectively rated)

  Autobiographical memory ability will be subjectively rated using the Autobiographical Recollection Test (ART), (Berntsen et al., 2019).

  Baseline (week 1) and follow up (week 14)

• Autobiographical Memory ability (subjectively rated on SAM)

  Autobiographical memory ability will also be subjectively rated using the survey of Autobiographical memory (SAM), (Palombo et al., 2012)

  Baseline (week 1) and follow up (week 14)

Secondary Outcomes (10)

• Functional ability in tasks of everyday living

  Baseline (week 1) and follow up (week 14)

• Quality of life for the individual with Alzheimer's disease (subjective)

  Baseline (week 1) and follow up (week 14)

• Level of Depression experienced by the person with AD (subjective)

  Baseline (week 1) and follow up (week 14)

• Cognitive ability of the person with AD

  Baseline (week 1) and follow up (week 14)

• Verbal learning ability for the person with AD

  Baseline (week 1) and follow up (week 14)

Study Arms (2)

Personalised AMPER

EXPERIMENTAL

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).

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

Non-personalised AMPER

ACTIVE COMPARATOR

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.

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

Interventions

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

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.

Personalised AMPER

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

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.

Non-personalised AMPER

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Strathclyde: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

University of Strathclyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Matthew Jamieson, PhD

CONTACT

+44 7717780272; matthew.jamieson@strath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

GB (1)