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NCT Number: NCT06894953

AMPER Proof of Concept Study

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.

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Key information

Conditions

Alzheimer's Dementia (AD) Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Quality of autobiographical memory during AMPER use

    Time frame: 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).

  2. Autobiographical Memory ability (objectively rated)

    Time frame: Baseline (week 1) and follow up (week 14)

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

  3. Autobiographical Memory ability (subjectively rated)

    Time frame: 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).

  4. Autobiographical Memory ability (subjectively rated on SAM)

    Time frame: 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 outcomes

  1. Functional ability in tasks of everyday living

    Time frame: Baseline (week 1) and follow up (week 14)

    Instrumental Activities of Daily Living (IADL), (Lawton & Brody, 1969)

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

    Time frame: Baseline (week 1) and follow up (week 14)

    Quality of life Alzheimer's Disease (Logsdon et al., 1999)

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

    Time frame: Baseline (week 1) and follow up (week 14)

    Geriatric Depression Scale (GDS), (Yesavage et al., 1982),

  4. Cognitive ability of the person with AD

    Time frame: Baseline (week 1) and follow up (week 14)

    Addenbrooke's Cognitive Examination ACE-III (Mioshi et al., 2006)

  5. Verbal learning ability for the person with AD

    Time frame: Baseline (week 1) and follow up (week 14)

    Hopkins Verbal Learning Test (HVLT) (Benedict et al., 1998)

  6. Short term verbal memory for person with AD

    Time frame: Baseline (week 1) and follow up (week 14)

    Digit Span forwards and backwards from the Wechsler Adult Intelligence Scale (4th edition), (Wechsler, 2008)

  7. Executive functioning for person with AD

    Time frame: Baseline (week 1) and follow up (week 14)

    Trail Making Test (Reitan, & Wolfson, 1985)

  8. Modified Hachinski Ischemia Scale score for person with AD

    Time frame: Baseline (week 1) and follow up (week 14)

    Modified Hachinski Ischemia Scale (mHIS) (Hachinski et al., 2012)

  9. Self-esteem for the person with AD

    Time frame: Baseline (week 1) and follow up (week 14)

    The Rosenberg Self Esteem scale (Rosenberg, 1965)

  10. Technology acceptance for person with AD

    Time frame: Baseline (week 1) and follow up (week 14)

    The ALMERE questionnaire (Heerink et al., 2010).

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Jamieson, PhD

CONTACT

[email protected]

+44 7717780272

Sponsors and collaborators

Lead sponsor

University of Strathclyde

Other

Collaborators

  • NHS Greater Glasgow and Clyde

Registry information

Official study title

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

Acronym: AMPER

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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