Clinical trial: Neuropsychological and Neurophysiological Effects of Cognitive Stimulation in Patients With Alzheimer's Disease and Mild Cognitive Impairment (NCT03784183)

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 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? 1