Status:
UNKNOWN
Neuropsychological and Neurophysiological Effects of Cognitive Stimulation in Patients With Alzheimer's Disease and Mild Cognitive Impairment
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60-85 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03784183
Start Date
September 27 2018
End Date
October 1 2020
Last Update
December 21 2018
Active Locations (1)
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1
Department of Human Neuroscience, Sapienza University of Rome
Rome, Italy, 00185