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

University of Roma La Sapienza

Status

Unknown

Conditions

Alzheimer Disease

Treatments

Other: Cognitive Stimulation (CS)

Study type

Interventional

Funder types

Other

Identifiers

NCT03784183

BSP-2018

Details and patient eligibility

About

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.

Enrollment

126 estimated patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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
- 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)
- 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

126 participants in 6 patient groups

moderate AD-experimental

Experimental group

Description:

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.

Treatment:

Other: Cognitive Stimulation (CS)

mild AD-experimental

Experimental group

Description:

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

Treatment:

Other: Cognitive Stimulation (CS)

MCI-experimental

Experimental group

Description:

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