NCT05433493

Effect of Individual Cognitive Stimulation on Memory and Executive Function in Older Adults With Alzheimer's Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Rsocialform - Geriatria, Lda · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia
• Neurocognitive Disorders
• Cognitive Impairment
• Cognitive Dysfunction
• Cognitive Decline

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive stimulation	The intervention program will have 24 sessions (base scheme of 4 series of 6 sessions), lasting approximately 45 min and will be developed according to the following structure: - welcoming (greeting to the participant) (5 min); - orientation to reality (10 min); - main cognitive stimulation activity (25 min); - return to calm and evaluation of the session (5 min). The CS sessions will have an individual format and will be conducted by a professional with experience in CS and previously trained in this intervention. The intervention sessions will include several activities based on the CS principles, with evidence suggesting positive participant effects. The CS sessions will be carried out using material, developed by the principal investigator, in digital format (power point presentations). There will be no repetition of activities, and throughout the base CS program, the degree of difficulty of the exercises will be adjusted based on the dementia stage of the participant.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-03-31
• Completion: 2023-10-06
• First posted: 2022-06-27
• Last updated: 2023-10-16

Locations

14 sites across 1 country: Portugal