Are anti-dementia drugs useful in advanced dementia?

Randomized, pragmátic, open-label clinical trial with blind evaluator, to evaluate the efficacy efficacy of continuing drug treatment in patients with advanced dementia.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000042-22-ES

Enrollment

Unknown

Registered

2017-03-10

Start date

2017-05-11

Completion date

Unknown

Last updated

2017-05-22

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

Conditions

Advanced dementia

Interventions

Pharmaceutical Form: INN or Proposed INN: DONEPEZIL CAS Number: 120014-06-4 Concentration unit: mg milligram(s) Concentration type: not less then Concentration number: 5-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with severe Alzheimer's disease, with or without a coexisting diagnosis of vascular dementia - Score of =10 on the Standardized Mini-Mental State - Previously treatred with ChI (with or without memantine) for at least 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 302

Exclusion criteria

Exclusion criteria: - Patients with another type of advanced dementia. - Life expectancy less than 1 year

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of maintaining drug therapy for dementia (IACh and / or memantine) versus withdrawal in patients with advanced dementia in terms of time to institutionalization and / or progression of disability, defined as loss of 2 of 4 basic functions, or 6 of 11 instrumental functions, according to the activities of the BADLS scale at 12 months.;Secondary Objective: To assess the effect of maintaining drug therapy for dementia (IACh and / or memantine) versus withdrawal in patients with advanced dementia in terms of changes in functional status, cognitive status, patient quality of life, and caregiver burden and cost-effectiveness of the intervention;Primary end point(s): Time to nursing home placement or progression of disabiliy, defined by loss of either two of four basic, or six of 11 instrumental, activities on the Bristol activities of daily living scale (BADLS) at 12 months;Timepoint(s) of evaluation of this end point: 1,3,6 and 12 months	—

Measure

Time frame

Main Objective: To assess the effect of maintaining drug therapy for dementia (IACh and / or memantine) versus withdrawal in patients with advanced dementia in terms of time to institutionalization and / or progression of disability, defined as loss of 2 of 4 basic functions, or 6 of 11 instrumental functions, according to the activities of the BADLS scale at 12 months.;Secondary Objective: To assess the effect of maintaining drug therapy for dementia (IACh and / or memantine) versus withdrawal in patients with advanced dementia in terms of changes in functional status, cognitive status, patient quality of life, and caregiver burden and cost-effectiveness of the intervention;Primary end point(s): Time to nursing home placement or progression of disabiliy, defined by loss of either two of four basic, or six of 11 instrumental, activities on the Bristol activities of daily living scale (BADLS) at 12 months;Timepoint(s) of evaluation of this end point: 1,3,6 and 12 months

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Secondary

Measure	Time frame
Secondary end point(s): - Functional status assesed as changes in the BADLS and FAST scale at 1,3,6 and 12 months - Cognitive status assesed as changes in the MMSE and SIB-s scale at 1,3,6 and 12 months. - Quality of life assesed as changes in the QUALID scale at 1,3,6 and 12 months and the EuroQol at 12 months. - Changes on the NPI-Q at 1,3,6 and 12 months. - Changes in the Clinical Global Impressions Scale at 12 months. - Caregiver burden: changes in the Zarit scale at 12 months. - Resource Utilization in Dementia and cost-effectiviness of the intervention;Timepoint(s) of evaluation of this end point: 1,3,6 and 12 months	—

Measure

Time frame

Secondary end point(s): - Functional status assesed as changes in the BADLS and FAST scale at 1,3,6 and 12 months - Cognitive status assesed as changes in the MMSE and SIB-s scale at 1,3,6 and 12 months. - Quality of life assesed as changes in the QUALID scale at 1,3,6 and 12 months and the EuroQol at 12 months. - Changes on the NPI-Q at 1,3,6 and 12 months. - Changes in the Clinical Global Impressions Scale at 12 months. - Caregiver burden: changes in the Zarit scale at 12 months. - Resource Utilization in Dementia and cost-effectiviness of the intervention;Timepoint(s) of evaluation of this end point: 1,3,6 and 12 months

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Countries

Spain

Contacts

Public ContactUNITAT D'INVESTIGACIÓ

GAP MALLORCA

ainasoler@ibsalut.caib.es3497117 58 976702

Outcome results

None listed

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