Neuropsychological and Neurophysiological Effects of Cognitive Stimulation in Patients With Alzheimer's Disease and Mild Cognitive Impairment

NCT03784183 | Unknown

• 1 other identifier: BSP-2018
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Change in global cognition as assessed by Mini Mental State Examination

  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.

  24 and 48 weeks

• Change in dementia severity as assessed by Clinical Dementia Rating Scale

  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.

  24 and 48 weeks

Secondary Outcomes (7)

• 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

Study Arms (6)

moderate AD-experimental

EXPERIMENTAL

Experimental Intervention: The CS shall be carried out in groups (5-7 participants), twice a week. Each session lasts 90 minutes. CS sessions begin with a training for temporal and spatial orientation in which participants are asked to recognize and recall the date and the place with the help of some environmental aids (calendars, clocks, pictures and maps). Then the participants complete an array of cognitive tasks for memory, attention, language, visuo-spatial functions and executive functions. These tasks range from individual paper-and-pencil exercises to verbal-learning exercises that have to be solved by the group.

Other: Cognitive Stimulation (CS)

mild AD-experimental

EXPERIMENTAL

Experimental Intervention: the same of the "moderate AD-experimental" arm

Other: Cognitive Stimulation (CS)

MCI-experimental

EXPERIMENTAL

Experimental Intervention: the same of the "moderate AD-experimental" arm

Other: Cognitive Stimulation (CS)

moderate AD-placebo

NO INTERVENTION

mild AD-placebo

NO INTERVENTION

MCI-placebo

NO INTERVENTION

Interventions

Cognitive Stimulation (CS) OTHER

CS consists of a wide range of structured activities aimed at the general improvement of social functioning and the maintenance of different cognitive functions. It is a non-specific in-group approach that places particular emphasis on social interactions.

MCI-experimental; mild AD-experimental; moderate AD-experimental

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• moderate AD participants
• Clinical diagnosis of probable AD (National Institute on Aging and Alzheimer's Association criteria)
• \< Clinical Dementia Rating Scale \< 3
• ≤ 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)
• \> Mini-Mental State Examination \< 27/30
• Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
• Geriatric Depression Scale (GDS) ≤ 6
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Human Neuroscience, Sapienza University of Rome

Rome, 00185, Italy

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind: Neuropsychologists and Neurophysiologists are prevented from having knowledge of the intervention assigned to the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Human Neuroscience

Model Details: A Randomized, Single-Blind, Placebo-Controlled, Parallel-Group

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 21, 2018
• Study Start: September 27, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 21, 2018

Record last verified: 2018-11

Locations

IT (1)