AMPER Proof of Concept Study (AMPER)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer's Dementia (AD)
• Intervention / Treatment: Device: Personalised Agent-based Memory Prosthesis to Encourage Reminiscing (AMPER); Device: Non-Personalised Agent-based Memory Prosthesis to Encourage Reminiscing (AMPER)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Jamieson, PhD; Phone Number: +44 7717780272; Email: matthew.jamieson@strath.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • University of Strathclyde
    • Contact: Matthew Jamieson; Phone Number: +44 7717780272; Email: matthew.jamieson@strath.ac.uk
    • Contact: Mario Parra, PhD; Email: mario.parra-rodriguez@strath.ac.uk
    • Contact: Lynsey Stewart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalised AMPER; 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); 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.
Active Comparator: Non-personalised AMPER; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional ability in tasks of everyday living	Instrumental Activities of Daily Living (IADL), (Lawton & Brody, 1969)	Baseline (week 1) and follow up (week 14)
Quality of life for the individual with Alzheimer's disease (subjective)	Quality of life Alzheimer's Disease (Logsdon et al., 1999)	Baseline (week 1) and follow up (week 14)
Level of Depression experienced by the person with AD (subjective)	Geriatric Depression Scale (GDS), (Yesavage et al., 1982),	Baseline (week 1) and follow up (week 14)
Cognitive ability of the person with AD	Addenbrooke's Cognitive Examination ACE-III (Mioshi et al., 2006)	Baseline (week 1) and follow up (week 14)
Verbal learning ability for the person with AD	Hopkins Verbal Learning Test (HVLT) (Benedict et al., 1998)	Baseline (week 1) and follow up (week 14)
Short term verbal memory for person with AD	Digit Span forwards and backwards from the Wechsler Adult Intelligence Scale (4th edition), (Wechsler, 2008)	Baseline (week 1) and follow up (week 14)
Executive functioning for person with AD	Trail Making Test (Reitan, & Wolfson, 1985)	Baseline (week 1) and follow up (week 14)
Modified Hachinski Ischemia Scale score for person with AD	Modified Hachinski Ischemia Scale (mHIS) (Hachinski et al., 2012)	Baseline (week 1) and follow up (week 14)
Self-esteem for the person with AD	The Rosenberg Self Esteem scale (Rosenberg, 1965)	Baseline (week 1) and follow up (week 14)
Technology acceptance for person with AD	The ALMERE questionnaire (Heerink et al., 2010).	Baseline (week 1) and follow up (week 14)

Collaborators and Investigators

• Sponsor: University of Strathclyde
• Collaborators: NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Assistive technology; Dementia; Reminiscence; Azheimer's disease; Reminiscence technology; Intelligent Virtual Agent
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 341144; EP/V05564X/1 (Other Grant/Funding Number: UKRI EPSRC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No