Understanding social changes in people with Alzheimer’s disease

Social cognition and functioning in Alzheimer's dementia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN61917909

Enrollment

414

Registered

2023-06-28

Start date

2023-05-01

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia Nervous System Diseases

Interventions

Procedures: Main Social Cognition and Functioning in Alzheimer's Dementia (SOCIAL) Study The volunteer will meet with us on two occasions – the first study visit, and then a final visit after 1 year

Eligibility

Sex/Gender

All

Age

50 Years to 120 Years

Inclusion criteria

Inclusion criteria: People with Alzheimer’s dementia: 1. Clinical diagnosis of probable Alzheimer’s disease dementia made by dementia specialist clinic. 2. Mini-mental state examination score >= 20 or Addenbrooke’s Cognitive Examination III score >= 52 (consistent with mild dementia) 3. English speaking ability sufficient to be able to complete standardised social cognition tests (TASIT-S) which are only available in the English language Additional criteria for SOCIAL-RM study: 4. Possess an Android smartphone Family/friend informant: 1. Family/friend informant must see the person with Alzheimer’s disease at least monthly to be able to report on social functioning and other symptoms. 2. English speaking to be able to complete English language questionnaires

Exclusion criteria

Exclusion criteria: People with Alzheimer’s dementia: 1. Lack of mental capacity to consent to participate 2. Previous diagnosis of schizophrenia, severe traumatic brain injury, or autistic spectrum disorder 3. Aged under 50 years Family/friend informant 1. Lack of mental capacity to consent to participate 2. Diagnosis of dementia or other serious mental illness 3. Aged under 18 years

Design outcomes

Primary

Measure	Time frame
Social functioning is measured using the Social Functioning in Dementia (SF-DEM) Scale at baseline, 4 months, 8 months, 12 months	—

Secondary

Measure	Time frame
1. Social cognition including emotion recognition and theory of mind is measured using The Awareness of Social Inference Test short form at baseline and 12 months 2. Empathy is measured using the Interpersonal Reactivity Index at baseline and 12 months 3. Cognition is measured using the Addenbrooke’s Cognitive Examination at baseline and 12 months 4. Quality of life is measured using the Quality of Life in Alzheimer’s Disease scale at baseline and 12 months 5. Neuropsychiatric symptoms are measured using the Neuropsychiatric Inventory at baseline and 12 months 6. Depression is measured using the Cornell Scale for Depression in Dementia at baseline and 12 months 7. Activities of Daily living are measured using the Bristol Scale for ADLs at baseline and 12 months 8. Awareness of social behaviour is measured using the Revised Self-monitoring Scale at baseline and 12 months 9. Physical comorbidities are measured using the Charlson Comorbidity Index at baseline and 12 months	—

Measure

Time frame

1. Social cognition including emotion recognition and theory of mind is measured using The Awareness of Social Inference Test short form at baseline and 12 months 2. Empathy is measured using the Interpersonal Reactivity Index at baseline and 12 months 3. Cognition is measured using the Addenbrooke’s Cognitive Examination at baseline and 12 months 4. Quality of life is measured using the Quality of Life in Alzheimer’s Disease scale at baseline and 12 months 5. Neuropsychiatric symptoms are measured using the Neuropsychiatric Inventory at baseline and 12 months 6. Depression is measured using the Cornell Scale for Depression in Dementia at baseline and 12 months 7. Activities of Daily living are measured using the Bristol Scale for ADLs at baseline and 12 months 8. Awareness of social behaviour is measured using the Revised Self-monitoring Scale at baseline and 12 months 9. Physical comorbidities are measured using the Charlson Comorbidity Index at baseline and 12 months

—

Countries

England, United Kingdom

Contacts

Public ContactAndrew Sommerlad

a.sommerlad@ucl.ac.uk+44 (0) 20 7679 9248

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026