Clinical trial NCT03784183: Neuropsychological and Neurophysiological Effects of Cognitive Stimulation in Patients With Alzheimer's Disease and Mild Cognitive Impairment
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
Mild Cognitive Stimulation
Non Pharmacological Intervention
Cognitive Stimulation
Transcranial Magnetic Stimulation
Blink Reflex
Neuropsychological Evaluation
Randomized Controlled Trial
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Single-Blind, Placebo-Controlled, Parallel-Group
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. 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
   * Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
   * Geriatric Depression Scale (GDS) ≤ 6
3. MCI 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)
   * Mini-Mental State Examination ≥ 24/30
   * Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
   * Geriatric Depression Scale (GDS) ≤ 6

Exclusion Criteria for all the participants (moderate AD, mild AD and MCI):

* Any medical or neurological condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the subject's cognitive impairment.
* Clinically significant psychiatric illness (e.g., uncontrolled major depression, bipolar affective disorder) within 6 months prior to the enrolment.
* Any medications that, in the opinion of the Investigator, may contribute to cognitive impairment or impair the subject's ability to perform cognitive testing or complete study procedures.
* Contraindications to Transcranial Magnetic Stimulation (history of epilepsy or seizures/presence of pacemaker).
* Subject currently living in an organized care facility with extensive intervention and/or support of daily living activities.
* Inability to comply with study requirements and commitments
* Has not one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the subject as to be able to provide accurate information about the subject's cognitive and functional abilities.

Primary outcomes:
measure: Change in global cognition as assessed by Mini Mental State Examination
timeFrame: 24 and 48 weeks
measure: Change in dementia severity as assessed by Clinical Dementia Rating Scale
timeFrame: 24 and 48 weeks
Secondary outcomes:
measure: Change in frontal functions as assessed by Frontal Assessment Battery
timeFrame: 24 and 48 weeks
measure: Change in verbal memory as assessed by Rey Auditory Verbal Learning Test
timeFrame: 24 and 48 weeks
measure: Change in attention as assessed by Visual Search Test
timeFrame: 24 and 48 weeks
measure: Change in visuospatial functions as assessed by Clock Drawing Test
timeFrame: 24 and 48 weeks
measure: Change in naming as assessed by Boston Naming Test
timeFrame: 24 and 48 weeks
measure: Change in synaptic plasticity as assessed by Paired Associative Stimulation
timeFrame: 24 and 48 weeks
measure: Change in blinking as assessed by Blink Rate Evaluation
timeFrame: 24 and 48 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Human Neuroscience, Sapienza University of Rome
Study officials:
References: