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DementiaNCT06372002

Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia

A study testing Cognitive Stimulation Therapy (CST) in people with Dementia and Neurocognitive Disorders, run by Instituto de Mayores y Servicios Sociales (IMSERSO) at 46 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to evaluate the effectiveness and cost-effectiveness of CST-ES, the Spanish adaptation of Cognitive Stimulation Therapy (CST), to improve cognition and quality of life in people with mild to moderate dementia. Read more about this study

Who is it for?
Any age
What is being tested?
Cognitive Stimulation Therapy (CST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
683 participants
Where
46 sitesSpain
Study dates
16 Oct 2023to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Users of any of the sites (Associations of Families of People with Dementia) participating in the study.
  • Individuals with a clinical diagnosis of neurocognitive disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5; APA, 2013), including Alzheimer's Disease (AD), Vascular Dementia (VD), mixed dementia (MxD), Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD), Mild cognitive impairment or dementia due to Parkinson's disease (PD).
  • Mild cognitive impairment or mild to moderate dementia (MMSE greater than 10).
  • People who can be able to communicate and understand enough to participate in group activities.
  • People who can participate in a group activity for at least 45 minutes.
  • Signing of informed consent by the person with dementia or the legal guardian.

Who cannot join

  • Presence of sensory limitations that prevent participation in the sessions.
  • Health problems that prevent or hinder their participation in the sessions.

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Spain46 sites

  • Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca

    Alcoy, Alicante

  • ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí)

    Algemesí, Valencia

  • AFA Alginet

    Alginet, Valencia

  • AFA Alicante

    Alicante

  • Alzheimer Ávila

    Ávila

  • Centre de Día AFA Barcelona

    Barcelona

  • AFA Benavente y Comarca

    Benavente, Zamora

  • Centro de estimulación y Rehabilitación "La LLimera" de AFABALS

    Benifaió, Valencia

  • Club de la memoria - Alzhei Cáceres

    Cáceres

  • AFA Alzhe de Cadiz

    Cadiz

  • AFA Castalla y Onil

    Castalla, Alicante

  • AFA Faro de Chipiona

    Chipiona, Cádiz

  • Asociación San Rafael de Alzheimer y Otras Demencias

    Córdoba

  • Centro Alois II

    Cornellà de Llobregat, Barcelona

  • Afa Puerto

    El Puerto de Santa María, Cádiz

  • AFA Elda, Petrer y Comarca del Medio Vinalopo

    Elda, Alicante

  • Centro de día Alzheimer Estepona

    Estepona, Málaga

  • Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez

    Fernán Núñez, Córdoba

  • AFEAVA

    Hervás, Cáceres

  • AFA Huelva

    Huelva

  • Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI)

    Iniesta, Cuenca

  • Asociación de Alzheimer "Virgen del Castillo"

    Lebrija, Sevilla

  • Alzheimer León

    León

  • Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja)

    Logroño

  • Asociación Alzheimer y otras Demencias Lorca

    Lorca, Murcia

  • AFALU

    Lugo

  • AFA Málaga

    Málaga

  • Centro de Día Nieves Barranco

    Marbella, Málaga

  • Asociación de familiares de personas con Alzheimer y otras demencias del Maresme

    Mataró, Barcelona

  • Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez"

    Mérida, Badajoz

  • AFAMO

    Montilla, Córdoba

  • Asociación de familiares de enfermos de Alzheimer de Motril - Contigo

    Motril, Granada

  • AFAMA Pollença

    Pollença, Balearic Islands

  • Asociación Alzheimer Bierzo

    Ponferrada, León

  • AFA Pozuelo

    Pozuelo de Alarcón, Madrid

  • AFASUR Genil

    Puente-Genil, Córdoba

  • Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

    Salamanca, 37008

  • Afa Santa Marina Del Rey

    Santa Marina del Rey, León

  • AGADEA

    Santiago de Compostela

  • AFATA Asociación de familiares y amigos de personas con deterioro cognitivo, enfermedad de Alzheimer y otras demencias de Talavera de la Reina

    Talavera de la Reina, Toledo

  • Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca

    Tàrrega, Lleida

  • AFA Teulada - Moraira (Marina Alta)

    Teulada, Alicante

  • AFAV (Asociación Familiares Enfermos de Alzheimer Valencia)

    Valencia

  • AFADAX

    Vélez-Málaga, Málaga

  • Asociación Familiares de Personas con Alzheimer de Villena y Comarca

    Villena, Alicante

  • AFARABA

    Vitoria-Gasteiz, Álava

Other trials in Spain

About this study

Official title: Effectiveness and Cost-Effectiveness of of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia: A Randomized Controlled Multicenter Clinical Trial

This study aims to evaluate the effectiveness and cost-effectiveness of CST-ES, the Spanish adaptation of Cognitive Stimulation Therapy (CST), to improve cognition and quality of life in people with mild to moderate dementia.

The evaluation will be conducted as a pragmatic multicenter randomized controlled clinical trial. Participants will be randomized to receive 7 weeks of CST-ES followed by 24 weeks of maintenance CST-ES (intervention group) or to continue their usual treatment (control group).

Read the detailed description

Spain is one of the countries with the most aged population, due to the increase in life expectancy and the decrease in the birth rate. As a result, the number of people affected by age-related pathologies, such as dementia, has increased. Dementia affects more than 700,000 people in Spain and it is expected that this number will be nearly two million people by 2050. For this reason, the Comprehensive Plan for Alzheimer's Disease and Other Dementias 2019-2023 states that addressing dementia is a public health priority and a major social and health problem.

To improve the quality of life of patients with dementia and their families, a wide variety of non-pharmacological therapies (NPT) have been developed, making cognitive interventions one of the most widespread. Although in Spain the term cognitive stimulation is mostly used in a generic way that includes different intervention modalities, at a conceptual level three types of cognitive interventions have been described: cognitive stimulation, cognitive training, and cognitive rehabilitation. In summary, cognitive stimulation increases orientation and global cognitive status, whilst cognitive training aims to restore specific cognitive functions, and cognitive rehabilitation aims to preserve functionality in everyday contexts. Although distinguishing between these cognition-oriented interventions is not always easy, cognitive stimulation has probed the most efficacy, with significant benefits on cognitive function compared to those obtained with acetylcholinesterase inhibitors and positive effects on quality of life, well-being, communication, and social interaction.

Cognitive Stimulation Therapy (CST) is a cognitive intervention for mild to moderate dementia that was developed in the United Kingdom and derived from those therapies that had shown the most promising results, combining their most effective elements. The original CST program consists of 14 45-minute sessions delivered twice a week for 7 weeks. There is also a maintenance program that includes 24 additional sessions (one session per week). CST is thought to provide a positive environment, with continuity and consistency between sessions to support memories formation. Its key principles include person-centered attention, consideration of the interests and abilities of every participant, use of implicit rather than explicit learning, focusing on opinions rather than facts, stimulation of all senses and cognitive skills, and use of reminiscence to orientate in the present moment. CST focuses on the cognitive strengths of people with dementia, reducing the sense of failure and increasing their confidence. Positive reinforcement of questioning, thinking, and interacting can also lead to more positive self-evaluation, increased communication, and better use of cognitive skills in daily life.

A manual has been published with the original CST intervention (Making a Difference) and another with the maintenance program (Making a Difference 2), which includes the basic principles of the intervention, each of the sessions developed, details of the materials needed, and how to monitor the process.

CST has shown significant benefits in general cognitive function, as well as improvements in specific cognitive functions such as communication and language, memory, orientation, and praxis. The program has also been shown to improve the quality of life of the participants. In addition, CST is effective independent of acetylcholinesterase inhibitor treatment, and cognitive benefits are comparable to those obtained with this medication. CST is a relatively unexpensive and more cost-effective intervention than usual care. As a result of these findings, CST has been recommended by organizations such as Alzheimer's Disease International or the National Institute for Health and Clinical Excellence and the Social Care Institute for Excellence, translated and adapted into several languages, and offered in at least 35 countries.

Although there is a significant amount of cognitive stimulation materials available in Spain, none of the published programs has a level of evidence comparable to that of CST. Given the need for evidence-based tools and materials to respond to the needs of people with dementia, the National Reference Center for the Care of People with Alzheimer's Disease and Other Dementias (CREA) has undertaken a process of translation and cultural adaptation of the two published CST manuals to the Spanish language and culture (CST-ES). Once the adaptation is completed, a study protocol is developed to evaluate the effectiveness and cost-effectiveness of the CST-ES program to improve cognitive performance and quality of life in people with mild to moderate dementia. Afterward, a multicenter study will be conducted using a randomized clinical trial methodology.

Hypothesis

  • After the 7 weeks of CST-ES, participants in the intervention group will improve their cognitive scores, whilst participants in the control group will either maintain or worsen their scores.
  • Participants in the CST-ES group will improve their quality of life.
  • Participants who continue with the CST-ES maintenance program will experience cognitive benefits compared to participants in the usual treatment control group.
  • The CST-ES maintenance program will increase the quality-of-life benefits compared to the control group.
  • Intervention with CST-ES and maintenance of CST-ES will be efficient compared to usual treatment.

Objectives

The main objectives of the study are:

  • To compare the effectiveness of CST-ES intervention followed by maintenance CST-ES with usual treatment to improve cognition and quality of life in people with mild to moderate dementia.

The following is proposed as a secondary objective:

  • Perform a cost-effectiveness and cost-utility analysis comparing the direct costs associated with CST-ES and usual treatment with the outcomes of the two alternatives.
Being tested
Cognitive Stimulation Therapy (CST)
Keywords
Dementia, Neurocognitive Disorders, Mild Cognitive Impairment, Cognitive stimulation, cognition, quality of life, neuropsychiatric symptoms, older adult, cognition oriented treatment, cost-effectiveness
Medical subject headings
Dementia, Neurocognitive Disorders, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Stimulation Therapy (CST)Behavioural

    Also called Maintenance CST (mCST), Cognitive Stimulation Therapy España (CST-ES), Cognitive Stimulation Therapy España de mantenimiento (mCST-ES)

    The intervention will consist of the Spanish adapted version of Cognitive Stimulation Therapy (CST) followed by the Maintenance CST program.

    CST is a cognitive intervention for treating mild to moderate dementia consisting of fourteen 45-minute group sessions that take place twice a week for 7 weeks. Each session follows a main topic (reminiscing about the person's life, current events, word games…) and is led by two group facilitators. The same structure is followed in every CST session: 1. Introduction (5 minutes). 2. Main Activity (25 minutes). 3. Closing (5 minutes).

    The Maintenance CST program follows the principles and structure of the original CST program and consists of 24 sessions, one per week, that will be administered after the original program.

    The topic, activities, and materials required for each session are specified in the CST-ES manuals, which also provide the key principles that should guide the intervention and other information necessary for its implementation.

Study groups in NCT06372002
Study groupRoleWhat they receive
Cognitive Stimulation TherapyExperimentalParticipants assigned to the intervention group will undergo 14 CST sessions, twice a week, for 7 weeks, in addition to continuing their standard care. Participants will then receive the CST Maintenance program, which consists of 24 sessions, once a week for 24 weeks, in addition to continuing their standard care.
Receives: Behavioral: Cognitive Stimulation Therapy (CST)
ControlNo interventionParticipants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

    The ADAS-Cog scale will be used, a test designed to assess cognition in people with AD. The ADAS-Cog takes approximately 30-40 minutes to complete and includes eleven tests that assess word recall, object and finger naming, verbal command comprehension, constructive praxis, ideational praxis, word recognition, expressive language, comprehension, and word finding difficulties. The maximum score is 70 points, and higher scores indicate greater severity of cognitive deficits. Due to its psychometric properties, it has been widely used in clinical pharmacological trials for AD to assess cognitive change throughout time.

    Measured: Baseline (T0)

  2. Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

    The ADAS-Cog scale will be used, a test designed to assess cognition in people with AD. The ADAS-Cog takes approximately 30-40 minutes to complete and includes eleven tests that assess word recall, object and finger naming, verbal command comprehension, constructive praxis, ideational praxis, word recognition, expressive language, comprehension, and word finding difficulties. The maximum score is 70 points, and higher scores indicate greater severity of cognitive deficits. Due to its psychometric properties, it has been widely used in clinical pharmacological trials for AD to assess cognitive change throughout time.

    Measured: 7 weeks after the start of the CST-ES program (First follow-up T1)

  3. Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

    The ADAS-Cog scale will be used, a test designed to assess cognition in people with AD. The ADAS-Cog takes approximately 30-40 minutes to complete and includes eleven tests that assess word recall, object and finger naming, verbal command comprehension, constructive praxis, ideational praxis, word recognition, expressive language, comprehension, and word finding difficulties. The maximum score is 70 points, and higher scores indicate greater severity of cognitive deficits. Due to its psychometric properties, it has been widely used in clinical pharmacological trials for AD to assess cognitive change throughout time.

    Measured: 24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)

  4. Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

    Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.

    Measured: Baseline (T0)

  5. Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

    Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.

    Measured: 7 weeks after the start of the CST-ES program (First follow-up T1)

  6. Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

    Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.

    Measured: 24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)

Secondary outcomes (6)

  1. Cognitive functioning assessed through Mini-Mental State Examination (MMSE)

    Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

    Measured: Baseline (T0)

  2. Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE)

    Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

    Measured: 7 weeks after the start of the CST-ES program (First follow-up T1)

  3. Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE)

    Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

    Measured: 24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)

  4. Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)

    EuroQol-5D 5-level version (EQ-5D-5L). The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way, an index is obtained that can be used directly or combined with life years to calculate quality-adjusted life years (QALYs).

    Measured: Baseline (T0)

  5. Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)

    EuroQol-5D 5-level version (EQ-5D-5L). The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way, an index is obtained that can be used directly or combined with life years to calculate quality-adjusted life years (QALYs).

    Measured: 7 weeks after the start of the CST-ES program (First follow-up T1)

  6. Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)

    EuroQol-5D 5-level version (EQ-5D-5L). The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way, an index is obtained that can be used directly or combined with life years to calculate quality-adjusted life years (QALYs).

    Measured: 24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start16 Oct 2023
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A pragmatic, multicenter, randomized, controlled clinical trial is proposed to compare treatment with CST-ES followed by maintenance treatment with CST-ES with treatment as usual: * First Phase: Participants who meet the inclusion criteria will be randomized to the CST-ES intervention group or a treatment-as-usual control group. Participants assigned to the intervention group will receive two sessions of CST-ES per week for 7 weeks, also they will continue their usual treatment. Participants in the control group will receive their usual treatment during the development of the study. * Second Phase: After the first phase is completed, participants assigned to the intervention group will receive one session of maintenance CST-ES per week for 24 weeks besides continuing their usual treatment, whereas participants in the control group will continue their usual treatment during this second phase.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
683 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06372002
Sponsor's protocol ID
05/23
Status last verified
Apr 2024
First submitted
11 Apr 2024
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Gavelin HM, Lampit A, Hallock H, Sabates J, Bahar-Fuchs A. Cognition-Oriented Treatments for Older Adults: a Systematic Overview of Systematic Reviews. Neuropsychol Rev. 2020 Jun;30(2):167-193. doi: 10.1007/s11065-020-09434-8. Epub 2020 Apr 7.

    PubMed 32266520

  • Gomez-Gallego M, Gomez-Amor J, Gomez-Garcia J. [Validation of the Spanish version of the QoL-AD Scale in alzheimer disease patients, their carers, and health professionals]. Neurologia. 2012 Jan;27(1):4-10. doi: 10.1016/j.nrl.2011.03.006. Epub 2011 May 12. Spanish.

    PubMed 21570161

  • Hall L, Orrell M, Stott J, Spector A. Cognitive stimulation therapy (CST): neuropsychological mechanisms of change. Int Psychogeriatr. 2013 Mar;25(3):479-89. doi: 10.1017/S1041610212001822. Epub 2012 Nov 12.

    PubMed 23146408

  • Hernandez G, Garin O, Pardo Y, Vilagut G, Pont A, Suarez M, Neira M, Rajmil L, Gorostiza I, Ramallo-Farina Y, Cabases J, Alonso J, Ferrer M. Validity of the EQ-5D-5L and reference norms for the Spanish population. Qual Life Res. 2018 Sep;27(9):2337-2348. doi: 10.1007/s11136-018-1877-5. Epub 2018 May 16.

    PubMed 29767329

  • Knapp M, Thorgrimsen L, Patel A, Spector A, Hallam A, Woods B, Orrell M. Cognitive stimulation therapy for people with dementia: cost-effectiveness analysis. Br J Psychiatry. 2006 Jun;188:574-80. doi: 10.1192/bjp.bp.105.010561.

    PubMed 16738349

  • Blesa R, Pujol M, Aguilar M, Santacruz P, Bertran-Serra I, Hernandez G, Sol JM, Pena-Casanova J; NORMACODEM Group. NORMAlisation of Cognitive and Functional Instruments for DEMentia. Clinical validity of the 'mini-mental state' for Spanish speaking communities. Neuropsychologia. 2001;39(11):1150-7. doi: 10.1016/s0028-3932(01)00055-0.

    PubMed 11527552

  • Aguirre E, Woods RT, Spector A, Orrell M. Cognitive stimulation for dementia: a systematic review of the evidence of effectiveness from randomised controlled trials. Ageing Res Rev. 2013 Jan;12(1):253-62. doi: 10.1016/j.arr.2012.07.001. Epub 2012 Aug 7.

    PubMed 22889599

  • Paddick SM, Mkenda S, Mbowe G, Kisoli A, Gray WK, Dotchin CL, Ternent L, Ogunniyi A, Kissima J, Olakehinde O, Mushi D, Walker RW. Cognitive stimulation therapy as a sustainable intervention for dementia in sub-Saharan Africa: feasibility and clinical efficacy using a stepped-wedge design. Int Psychogeriatr. 2017 Jun;29(6):979-989. doi: 10.1017/S1041610217000163. Epub 2017 Feb 22.

    PubMed 28222815

  • McDermott O, Charlesworth G, Hogervorst E, Stoner C, Moniz-Cook E, Spector A, Csipke E, Orrell M. Psychosocial interventions for people with dementia: a synthesis of systematic reviews. Aging Ment Health. 2019 Apr;23(4):393-403. doi: 10.1080/13607863.2017.1423031. Epub 2018 Jan 17.

    PubMed 29338323

  • Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.

    PubMed 12021425

  • Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.

    PubMed 6496779

  • Soto-Gordoa M, Arrospide A, Moreno-Izco F, Martinez-Lage P, Castilla I, Mar J. Projecting Burden of Dementia in Spain, 2010-2050: Impact of Modifying Risk Factors. J Alzheimers Dis. 2015;48(3):721-30. doi: 10.3233/JAD-150233.

    PubMed 26402090

  • Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.

    PubMed 12948999

  • Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD005562. doi: 10.1002/14651858.CD005562.pub2.

    PubMed 22336813

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Stimulation Therapy (CST) in people with Dementia and Neurocognitive Disorders, run by Instituto de Mayores y Servicios Sociales (IMSERSO) at 46 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) (time frame: Baseline (T0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06372002, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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