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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Keywords

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Alzheimer's Disease Mild Cognitive Stimulation Non Pharmacological Intervention Cognitive Stimulation Transcranial Magnetic Stimulation Blink Reflex Neuropsychological Evaluation Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Randomized, Single-Blind, Placebo-Controlled, Parallel-Group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single Blind: Neuropsychologists and Neurophysiologists are prevented from having knowledge of the intervention assigned to the participants.

Study Groups

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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

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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

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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

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Carlo de Lena

Department of Human Neuroscience

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Human Neuroscience, Sapienza University of Rome

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Carlo de Lena, MD

Role: primary

Alessandro Trebbastoni, MD, PhD

Role: backup

Other Identifiers

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BSP-2018

Identifier Type: -

Identifier Source: org_study_id