Clinical trial NCT05433493: Effect of Individual Cognitive Stimulation on Memory and Executive Function in Older Adults With Alzheimer's Disease
Official title: Effect of Individual Cognitive Stimulation on Memory and Executive Functioning in Older Adults With Mild to Moderate Alzheimer's Disease: A Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Neurocognitive Disorders
Cognitive Impairment
Cognitive Dysfunction
Cognitive Decline
Keywords: older adults
cognitive function
memory
executive function
dementia
cognitive stimulation therapy
cognition
neurocognitive disorders
individual therapy
non-pharmacological therapy
randomised controlled trial
Alzheimer disease
Lead sponsor: Rsocialform - Geriatria, Lda
Sponsor class: OTHER
Collaborators: name: Aveiro University
First posted: 2022-06-27
Enrollment: 142
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This multicentre study, with a randomised controlled repeated measures experimental design, will be conducted in several Portuguese institutions, which provide care and supportive services for older adults diagnosed with mild or moderate Alzheimer's disease (AD), with an aim to assess the effect of individual cognitive stimulation (CS) on memory and executive functioning. Participants in the intervention group will attend 24 individual CS sessions, twice weekly for 12 weeks. Participants in the control group will complete their usual routines without any activity restrictions.

Detailed description: Neurocognitive disorders (NCD) currently affect around 55 million people worldwide and expected to increase to 78 million by 2030 and 139 million by 2050, with Alzheimer's disease (AD) potentially accounting for 60-70% of dementia cases. Dementia is a syndrome, generally chronic or progressive in nature, that causes deterioration of cognitive function, particularly memory and executive functions, beyond what is expected in normal aging. However, there is evidence that in the early stages of NCD, people can learn and improve their cognitive functions through interventions such as CS. CS is a psychosocial intervention and a non-pharmacological therapy recommended by international practice guidelines for people with mild-to-moderate stage AD. However, it is also important to investigate whether NCD generates new skills or only preserves acquired skills, given that AD manifests initially and notably with deficits in memory and learning, sometimes accompanied by deficits in executive functions. Testing the effectiveness of CS by recruiting a representative sample from several Portuguese districts and using a CS programme with detailed and comprehendible content, may elicit relevant evidence in clinical practice, contribute to the development of social development programs and initiatives to ensure social protection and inclusion, promote recurrent therapeutic interventions in Portuguese institutions with provide care and supporting services for older adults with dementia, and strengthen research on non-pharmacological therapies. Thus, this multicentre, randomised controlled study is essential to analyse the effects of the individual CS on global cognitive function and specific cognitive domains (e.g., executive functioning, memory) in older adults with mild or moderate AD.

Eligibility criteria: Inclusion Criteria:

* Age 65 or over.
* Receive care and support services for older adults for at least three months.
* Alzheimer's disease, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
* Ability to communicate and understand.
* Native speakers of Portuguese.
* To have given informed consent for the project, duly completed and signed, after previous information.
* Total scores between 10 and 24 points on the Mini Mental State Examination.

Exclusion Criteria:

* Cannot read and write.
* Severe sensory and physical limitations and/or an acute or serious illness preventing participation in the CS sessions.
* Evidence of aggressive and disruptive behaviour, as indicated by the reference technicians of the institution to which the participant is linked.
* Consumption of psychoactive substances, taking neuroleptics and/or antipsychotics in the last two months.

Primary outcomes:
measure: Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
timeFrame: baseline
measure: Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)
timeFrame: 12 weeks after the beginning of the intervention
measure: Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)
timeFrame: 12 weeks after end of intervention
measure: Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
timeFrame: baseline
measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
timeFrame: 12 weeks after the beginning of the intervention
measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
timeFrame: 12 weeks after end of intervention
measure: Memory function evaluated through Memory Alteration Test (MAT)
timeFrame: baseline
measure: Change in memory function evaluated through Memory Alteration Test (MAT)
timeFrame: 12 weeks after the beginning of the intervention
measure: Change in memory function evaluated through Memory Alteration Test (MAT)
timeFrame: 12 weeks after end of intervention
measure: Memory function evaluated through Free and Cued Selective Reminding Test (FCSRT)
timeFrame: baseline
measure: Change in memory function evaluated through Free and Cued Selective Reminding Test (FCSRT)
timeFrame: 12 weeks after the beginning of the intervention
measure: Change in memory function evaluated through Free and Cued Selective Reminding Test (FCSRT)
timeFrame: 12 weeks after end of intervention
measure: Executive functions assessed through Frontal Assessment Battery (FAB)
timeFrame: baseline
measure: Change in executive functions assessed through Frontal Assessment Battery (FAB)
timeFrame: 12 weeks after the beginning of the intervention
measure: Change in executive functions assessed through Frontal Assessment Battery (FAB)
timeFrame: 12 weeks after end of intervention
measure: Executive functions assessed through Trail Making Test (TMT)
timeFrame: baseline
measure: Change in executive functions assessed through Trail Making Test (TMT)
timeFrame: 12 weeks after the beginning of the intervention
measure: Change in executive functions assessed through Trail Making Test (TMT)
timeFrame: 12 weeks after end of intervention
Secondary outcomes:
Other outcomes:
measure: Sociodemographic information gathered through the sociodemographic questionnaire
timeFrame: baseline
measure: Adherence to the intervention and dropouts evaluated through a session form
timeFrame: during the intervention
Locations:
city: Mealhada
country: Portugal
facility: Rsocialform - Geriatria, Lda
state: Aveiro
city: Aveiro
country: Portugal
facility: Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
city: Açores
country: Portugal
facility: Santa Casa da Misericórdia da Horta
city: Braga
country: Portugal
facility: Centro Social e Cultural S. Pedro de Bairro
city: Braga
country: Portugal
facility: Centro Social Vale do Homem - Casa da Alegria
city: Faro
country: Portugal
facility: Santa Casa da Misericórdia de Castro Marim
city: Guarda
country: Portugal
facility: Fundação João Bento Raimundo
city: Leiria
country: Portugal
facility: Santa Casa da Misericórdia de Alcobaça
city: Lisboa
country: Portugal
facility: Associação de Socorros da Freguesia de Turcifal
city: Lisboa
country: Portugal
facility: Centro de Apoio Social de Oeiras - IASFA
city: Lisboa
country: Portugal
facility: Inválidos do Comércio
city: Porto
country: Portugal
facility: Associação de Apoio Social de Perafita
city: Santarém
country: Portugal
facility: Santa Casa da Misericórdia de Coruche
city: Viana Do Castelo
country: Portugal
facility: Santa Casa da Misericórdia de Ponte de Lima
Study officials:
affiliation: Nursing School of Coimbra
name: Susana I Justo Henriques, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aveiro University
name: Óscar Ribeiro, PhD
role: STUDY_DIRECTOR
References: