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

NCT ID: NCT03784183

Last Updated: 2018-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2020-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

moderate AD-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.

Group Type: EXPERIMENTAL

Cognitive Stimulation (CS)

Intervention Type: 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.

mild AD-experimental

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

Group Type: EXPERIMENTAL

Cognitive Stimulation (CS)

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Cognitive Stimulation (CS)

Intervention Type: 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.

moderate AD-placebo

Group Type: NO_INTERVENTION

No interventions assigned to this group

mild AD-placebo

Group Type: NO_INTERVENTION

No interventions assigned to this group

MCI-placebo

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Stimulation (CS)

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.

Intervention Type: OTHER

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

• 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Carlo de Lena

Department of Human Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Human Neuroscience, Sapienza University of Rome

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Carlo de Lena, MD

Role: primary

carlo.delena@uniroma1.it

0649914028 ext. 0039

Alessandro Trebbastoni, MD, PhD

Role: backup

alessandro.trebbastoni@uniroma1.it

3491496146 ext. 0039

Other Identifiers

BSP-2018

Identifier Type: -

Identifier Source: org_study_id