A Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of a Non-Pharmacological Intervention of Cognitive Stimulation in Subjects With Alzheimer's Disease and Mild Cognitive Impairment: The Brain Stimulation Project.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Change in global cognition as assessed by Mini Mental State Examination
- Last Updated
- 7 years ago
Overview
Brief Summary
The present study aims to evaluate the effect of cognitive stimulation (CS) in participants with a diagnosis of moderate and mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) compared to control subjects not receiving any non-pharmacological interventions. Treated participants will receive a structured CS consisting of a wide range of activities aimed at the general improvement of social functioning and the maintenance of cognitive functions. The study consists of a 24-week treatment phase and a follow-up period of 24 weeks. During the treatment period, patients will receive two CS sessions a week. At baseline, all the participants undergo an extensive neuropsychological evaluation and a neurophysiological assessment aimed at studying the frequency of spontaneous blinking (blink rate) and cortical excitability and synaptic plasticity by means of the transcranial magnetic stimulation (TMS). Neuropsychological and neurophysiological evaluations will be repeated at the end of the treatment (week 24) and at the end of the follow-up period (week 48) in order to evaluate short- and long-term effects of CS. The hypothesis of this research is that CS may improve cognition and the neurophysiological parameters studied in treated participants compared to those untreated.
Investigators
Carlo de Lena
Department of Human Neuroscience
University of Roma La Sapienza
Eligibility Criteria
Inclusion Criteria
- •moderate AD participants
- •Clinical diagnosis of probable AD (National Institute on Aging and Alzheimer's Association criteria)
- •1 \< Clinical Dementia Rating Scale \< 3
- •13 ≤ Mini-Mental State Examination \< 20/30
- •Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
- •Geriatric Depression Scale (GDS) ≤ 6
- •mild AD participants
- •Clinical diagnosis of probable AD (National Institute on Aging and Alzheimer's Association criteria)
- •Clinical Dementia Rating Scale = 1 (memory box score ≥ 0.5)
- •20 \> Mini-Mental State Examination \< 27/30
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in global cognition as assessed by Mini Mental State Examination
Time Frame: 24 and 48 weeks
Change from baseline in Mini Mental State Examination score at Week 24 and 48. This scale investigates global cognition. Scale range: 0-30. Normal values \>24. Higher values represent a better outcome.
Change in dementia severity as assessed by Clinical Dementia Rating Scale
Time Frame: 24 and 48 weeks
Change from baseline in Clinical Dementia Rating Scale score at Week 24 and 48. This scale investigates global cognition and dementia severity. Scale range: 0-5. Normal values = 0. Higher values represent a worse outcome.
Secondary Outcomes
- Change in frontal functions as assessed by Frontal Assessment Battery(24 and 48 weeks)
- Change in verbal memory as assessed by Rey Auditory Verbal Learning Test(24 and 48 weeks)
- Change in attention as assessed by Visual Search Test(24 and 48 weeks)
- Change in visuospatial functions as assessed by Clock Drawing Test(24 and 48 weeks)
- Change in naming as assessed by Boston Naming Test(24 and 48 weeks)
- Change in synaptic plasticity as assessed by Paired Associative Stimulation(24 and 48 weeks)
- Change in blinking as assessed by Blink Rate Evaluation(24 and 48 weeks)