Clinical trial NCT06894953: AMPER Proof of Concept Study
Official title: Proof of Concept Study of the Personalised AMPER System (Agent-based Memory Prosthesis to Encourage Reminiscing).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer&#39;s Dementia (AD)
Keywords: Azheimer&#39;s disease
Dementia
Reminiscence
Reminiscence technology
Assistive technology
Intelligent Virtual Agent
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
First posted: 2025-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Quality of autobiographical memory during AMPER use
timeFrame: From enrollment to the end of AMPER use at 12 weeks
measure: Autobiographical Memory ability (objectively rated)
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Autobiographical Memory ability (subjectively rated)
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Autobiographical Memory ability (subjectively rated on SAM)
timeFrame: Baseline (week 1) and follow up (week 14)
Secondary outcomes:
measure: Functional ability in tasks of everyday living
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Quality of life for the individual with Alzheimer's disease (subjective)
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Level of Depression experienced by the person with AD (subjective)
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Cognitive ability of the person with AD
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Verbal learning ability for the person with AD
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Short term verbal memory for person with AD
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Executive functioning for person with AD
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Modified Hachinski Ischemia Scale score for person with AD
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Self-esteem for the person with AD
timeFrame: Baseline (week 1) and follow up (week 14)
measure: Technology acceptance for person with AD
timeFrame: Baseline (week 1) and follow up (week 14)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Strathclyde
Study officials:
References: