NCT04570215

Brief Summary

Aims and background Everyone forgets the names of people they should know at times. Having dementia makes this problem worse. People with dementia have told expressed they forget the names of people they care about and this can be upsetting and embarrassing. However, evidence shows that if people get enough practice, they can re-learn these names. The investigators, along with people with dementia and their carers, have created a fun therapy for people to get lots of practice so they can remember the names of people that are important to them. The main aim of the study is: To prove that Gotcha! therapy can help people with dementia to improve their ability to remember names. Another aim is: To find out if using the therapy is related to any changes in the brains of people with dementia. Design and methods Participants are provided with a computer tablet to practise at home. Participants are required to think of 6-10 familiar people (family and friends) whose names they forget and want to remember better. Participants also need to practise every day for about 30 minutes over a 6 week period so they get a large amount of therapy. Participants will have 7 testing appointments over 12 months. At three of these appointments participants will need to have a brain scan. These scans are carried out by trained University College London professionals and will take no longer than 30 minutes each. For the appointments where participants do not need to have a brain scan home testing can be arranged. The investigators organise and pay for all journeys to and from University College London. Participants Participants can get involved in our research if they:

  • Have ever experiences seeing a familiar person but can't remember their name
  • Have a diagnosis of dementia (Alzheimer's disease or mixed dementia).
  • Want to be part of an important and exciting research journey. Unfortunately a diagnosis of other any other types of dementia not mentioned above is not suitable for this study Patient and Public involvement The investigators have engaged with people from the Alzheimer's Society and local dementia carers groups, run many focus groups and interviewed people with dementia and their carers to co-design the therapy. At the end of our research participants are invited to University College London to learn about the results of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

5.2 years

First QC Date

May 29, 2020

Results QC Date

December 30, 2025

Last Update Submit

January 19, 2026

Conditions

Keywords

Digital TherapyDigital interventionTherapy app

Outcome Measures

Primary Outcomes (1)

  • Gotcha! Outcome Measure

    The GOM is a free naming test using images of the participants' 6-10 personalized faces that they wanted to practice on. The test was completed in person at the main time points (T1-T4) and remotely during the weekly pre-therapy and therapy blocks. It was delivered via the app and consisted of the horizontally flipped versions of the photos that appeared as training items in order to reduce the effects of identity priming (Schacter, et al. 2004). The images were displayed for 6 seconds with a 2 second fade out. Responses were audio recorded and checked for accuracy with each attempt scoring either 1 or 0. As the number of items in the GOM varied across participants, these raw scores were converted into percentages ((correct responses/total number of stimuli)\*100). The Famous Faces were tested using the same parameters at T1-T4 using a PowerPoint presentation.

    T1 (baseline = initial assessment) to T4 (immediately following 6 weeks of Gotcha! therapy)

Study Arms (2)

Gotcha! Therapy Application

ACTIVE COMPARATOR

Participants will receive the Gotcha therapy daily for six weeks.Participants are required to use the app everyday for a maximum of 45 minutes. After this time they enter a twelve week block with no therapy or maintenance of therapy (see Gotcha maintenance arm). This aim of this arm is to invesitgate the efficacy of the Gotcha therapy for proper-noun anomia in mild-moderate patients with dementia (Alzheimer's disease, vascular dementia and mixed)

Other: Gotcha! Therapy application

Gotcha! Therapy Application: Maintenance

ACTIVE COMPARATOR

Participants will receive the Gotcha therapy for six weeks as described in the Gotcha arm. After this time they enter a twelve week block of maintenance of therapy gains made in the initial six week therapy block. The maintenance block consists of a weekly test of the Gotcha outcome measure to monitor the therapy gains made during the therapy block. If any previously correctly named person is incorrectly named during these weekly tests then the participant must complete a 'top-up' therapy session. They will then be tested again the following week. The aim of this arm is to compare Gotcha maintenance with Gotcha, to see if extra testing and therapy is required to maintain gains made during an initial intense therapy block.

Other: Gotcha! Therapy applicationOther: Gotcha Therapy application: Maintenance

Interventions

Gotcha! will provide an app-based therapy for people with dementia who have difficulty naming people they know well. The therapy element works via mass practice and feedback to the users on a trial-by-trial basis. The DNI is very simple in a way; it just presents a long series of pictures for users to name. This DNI will use speech recognition (SR) software in order to make a binary decision as to whether the user said the correct word or not. This affects what the next trial (object to name) is and what auditory cue (if any) is provided the next time the user has to name the same item.

Also known as: Gotcha!
Gotcha! Therapy ApplicationGotcha! Therapy Application: Maintenance

Gotcha! Maintenance therapy is identical to Gotcha! but takes place over a longer period of time in an attenuated form.

Also known as: Gotcha Maintenance
Gotcha! Therapy Application: Maintenance

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Person with mild/moderate dementia
  • Self-reported proper naming difficulty which we will then assess at Time Point 1 English as their dominant language
  • Able to tolerate MRI brain scan
  • Able to give informed consent
  • Able to use the DNI (app)

You may not qualify if:

  • No diagnosis of developmental language disorders
  • No diagnosis of severe dementia or primary progressive aphasia
  • No major co-existing neurological or psychiatric diagnosis
  • No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or other metallic or electronic objects in the body, weight over 24 stone, claustrophobia or pregnancy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E6BT, United Kingdom

Location

MeSH Terms

Conditions

DementiaAlzheimer DiseaseAnomia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Prof Alexander Leff
Organization
UCL Queen Square Institute of Neurology

Study Officials

  • Alexander P Leff, Professor

    University College, London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2020

First Posted

September 30, 2020

Study Start

September 17, 2019

Primary Completion

December 4, 2024

Study Completion

December 4, 2024

Last Updated

January 22, 2026

Results First Posted

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations