Clinical trial: A Study of the Safety and Effectiveness of Two Doses of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease (NCT00253201)

Eligibility criteria:
Inclusion Criteria:

          -  Outpatients with a diagnosis of Alzheimer's disease according to the National
             Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and
             Related Disorders Association (NINCDS-ADRDA) criteria (including patients living
             independently in residential homes for the elderly or day patients)

          -  have mild to moderate dementia, as evidenced by a Mini-Mental Status Examination
             (MMSE) score of 11 - 24, and a score of at least 12 on the cognitive portion of the
             Alzheimer's Disease Assessment scale (ADAS-cog)

          -  history of at least a 6 months of gradual and progressive cognitive decline

          -  have a consistent informant to accompany the patient on scheduled visits

        Exclusion Criteria:

          -  Neurogenerative disorders such as Parkinson's disease

          -  dementia caused by small strokes or cerebrovascular disease

          -  cognitive impairment resulting from acute cerebral trauma, cerebral damage due to a
             lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant
             endocrine or metabolic disease, mental retardation, or a brain tumor

          -  having epilepsy, significant psychiatric disease, active peptic ulcer, clinically
             significant liver, kidney or lung disorders, or heart disease

          -  females of child bearing potential without adequate contraception
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? Entailment