AMPER Proof of Concept Study

Not Applicable

Not yet recruiting

• Conditions: Alzheimer's Dementia (AD)

• Registration Number: NCT06894953
• Lead Sponsor: University of Strathclyde

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-04-01
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of autobiographical memory during AMPER use	From enrollment to the end of AMPER use at 12 weeks	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).
Autobiographical Memory ability (objectively rated)	Baseline (week 1) and follow up (week 14)	Objective rating of Autobiographical Memory ability using the Autobiographical Memory Interview (Kopelman et al., 1989)
Autobiographical Memory ability (subjectively rated)	Baseline (week 1) and follow up (week 14)	Autobiographical memory ability will be subjectively rated using the Autobiographical Recollection Test (ART), (Berntsen et al., 2019).
Autobiographical Memory ability (subjectively rated on SAM)	Baseline (week 1) and follow up (week 14)	Autobiographical memory ability will also be subjectively rated using the survey of Autobiographical memory (SAM), (Palombo et al., 2012)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Strathclyde; 🇬🇧 Glasgow, United Kingdom