Evaluation of GRADIOR, a neuropsychological rehabilitation programme for people with mild dementia and mild cognitive impairment

Evaluation of GRADIOR, a neuropsychological rehabilitation programme for people with mild dementia and mild cognitive impairment - a multicentre single-blinded randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15742788

Enrollment

400

Registered

2017-06-12

Start date

2017-09-01

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Dementia, mild cognitive impairment Mental and Behavioural Disorders

Interventions

Eligible participants will undergo a preliminary baseline testing of all outcome measures. Subsequently, participants will be randomised in equal proportion between 4 groups receiving cognitive rehabi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females aged over 60 2. Formal diagnosis of dementia (meeting the DSM IV/TR5 criteria, Clinical Dementia Rating between 1 and 2, Geriatric Depression Scale score lower than 5) or MCI (meeting the Petersen criteria, Clinical Dementia Rating less than 0.5, Geriatric Depression Scale score lower than 5) 3. Capability making decisions 4. Having a reference caregiver 5. Being able to read and write in Spanish language

Exclusion criteria

Exclusion criteria: 1. Mayor physical illness or disability which could affect participation (hearing loss, blindness, etc) 2. Neurological illness (Huntington's disease, cerebro-vascular stroke, Parkinson's disease, dementia with Lewy body) 3. Psychiatric diagnosis (depression, psychosis, bipolar disorder) 4. History of substance dependence (alcoholism or alcohol related dementia) 5. Taking antipsychotic medication

Design outcomes

Primary

Measure	Time frame
Cognitive performance, measured using Spanish versions of the following tests at baseline, 4 months and 12 months: 1. Mini-Mental State Examination (MMSE) 2. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) 3. Clock Drawing Test (CDT) 4. WAIS III – Coding digit symbol 5. Calculus and Digit Span subtests 6. Rivermead pattern recognition test 7. Trail making test versions A and B (TMT) 8. Cambridge Cognitive Examination (CAMCog) – matrices subtest 9. Semantic and phonologic verbal fluency tests	—

Measure

Time frame

Cognitive performance, measured using Spanish versions of the following tests at baseline, 4 months and 12 months: 1. Mini-Mental State Examination (MMSE) 2. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) 3. Clock Drawing Test (CDT) 4. WAIS III – Coding digit symbol 5. Calculus and Digit Span subtests 6. Rivermead pattern recognition test 7. Trail making test versions A and B (TMT) 8. Cambridge Cognitive Examination (CAMCog) – matrices subtest 9. Semantic and phonologic verbal fluency tests

—

Secondary

Measure	Time frame
Assessed at baseline, at 4 and 12 months of the treatment and at 16 and 24 months in the follow-up: 1. Quality of life, assessed by the EuroQol EQ5D-5L 2. Depression symptoms, assessed by the Geriatric Depression Scale (GDS) 3. Activities of daily living and demographic information, health and use of services, assessed by the InterRAI-HC 4. Experience with technology, assessed by the Everyday Technology Use Questionnaire (ETUQ) 5. Quality of relationship with carer, assessed by the Quality of carer-patient relationship (QCPR) Carers participating in the trial complete the following measures at the same timepoints as above: 1. Caregiver burden, assessed by the Zarit test 2. Depression symptoms, assessed by the Beck Depression Inventory II (BDI-II) 3. Anxiety symptoms, assessed by the State-Trait Anxiety Inventory (STAI)	—

Measure

Time frame

Assessed at baseline, at 4 and 12 months of the treatment and at 16 and 24 months in the follow-up: 1. Quality of life, assessed by the EuroQol EQ5D-5L 2. Depression symptoms, assessed by the Geriatric Depression Scale (GDS) 3. Activities of daily living and demographic information, health and use of services, assessed by the InterRAI-HC 4. Experience with technology, assessed by the Everyday Technology Use Questionnaire (ETUQ) 5. Quality of relationship with carer, assessed by the Quality of carer-patient relationship (QCPR) Carers participating in the trial complete the following measures at the same timepoints as above: 1. Caregiver burden, assessed by the Zarit test 2. Depression symptoms, assessed by the Beck Depression Inventory II (BDI-II) 3. Anxiety symptoms, assessed by the State-Trait Anxiety Inventory (STAI)

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026