Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase IV-An Open-Label Prospective Study of Memantine in Institutionalized Patients With Severe Alzheimer's Disease and Significant Behavioural and Psychological Symptoms of Dementia
Brief Summary: Alzheimer's disease (AD) is the most common form of dementia and is characterized by both cognitive and behavioural symptoms ("Behavioural and Psychological Symptoms of Dementia"; BPSD). To date, there are only modestly effective treatments for BPSD, and these treatments are associated with an increased risk of mortality in elderly dementia patients. We plan to study whether treatment with medication memantine improves BPSD in severe AD patients. Thirty-two AD patients with significant BPSD, including agitation and aggression, will be treated for three months with memantine. Assessments of behavioural symptoms and global clinical outcomes will be completed after one, two and three months of treatment.


Options:
A: Inclusion Criteria:

1. Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.
2. Alzheimer's Disease only as per McKhann Criteria + Hachinski Score\<=4.
3. Moderately severe to severe Alzheimer's Disease (baseline MMSE \</=19).
4. Clinically significant agitation that requires treatment.
5. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) \> /=45.
6. Age \>/= 55.

Exclusion Criteria:

1. Memantine usage in the 4 weeks prior to the start of the study.
2. On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
3. Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.
4. Antiparkinsonian medication.
5. Hypersensitivity to memantine or any of the excipients in the formulation.
6. Severe renal impairment.
7. Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment.
8. Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.
9. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.
10. Severe, unstable or poorly controlled medical illness.
11. Any disability that may interfere with the patient completing the study procedure.
12. Active malignancy.
13. Delirium, pain or any medical illness as a clear cause of agitation.
14. Any important drug interactions: Prohibited during study and in the 14 days preceding enrollment/inclusion are: Analgesic dextromethorphan, Dopaminergics- amantadine, Warfarin due to theoretical INR prolongation.
B: Inclusion Criteria:

* Signed informed consent obtained from a legally acceptable representative
* Male or female \> 65 years of age, residing in long-term care
* Diagnosis and Statistical Manual of Mental Disorders (DSM-IV-TR) diagnosis of Dementia of the Alzheimer's type (code 290.1)
* Mini Mental State Examination total score ≤ 15
* Neuropsychiatric Inventory-Nursing Home Version total score \> 10, and a score \> 1 on the agitation/aggression subscale
* A current order for any prescription medication for behavioral and psychological symptoms of dementia (e.g. benzodiazepine, antipsychotic, trazodone), with at least 1 dose used in the prior 3 months
* Patients with a current order for any regularly administered psychotropic (example, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, trazodone, atypical antipsychotics, typical antipsychotics or cholinesterase inhibitors) must have been on a stable dose for 3 months prior to entry

Exclusion Criteria:

* Current evidence of any uncontrolled medical illness that would interfere with the subject's participation in the study
* Dementia due to any etiology other than Alzheimer's Disease
* Subjects experiencing significant difficulties ingesting oral medications
C: Inclusion Criteria:

* Ambulatory patients aged \>/= 50 years
* Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
* Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.
* Mini-Mental State Examination (MMSE) scores \>/= 3 and \</= 14 at Screening (Visit 1) and Baseline (Visit 2)
* Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.

Exclusion Criteria:

* Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.
* Patients who have taken memantine within one month of Screening (Visit 1)
* Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.
* Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.
* Patients who are receiving therapy with more than one AChEI.
* Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.
* Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
* Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.
* Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years
* Patients who had dementia that was complicated by other organic disease
* Patients who had dementia complicated by the presence of predominant delusions
D: Inclusion Criteria:

* Patients must have taken trial medication during the 24-month trial period of GAL-INT-8 and should be enrolled within 1 month after completion
* Patients and their primary caregiver give informed consent for the participation in the trial
* Patients must have remained in good health, as determined by medical history, complete physical examination and laboratory tests

Exclusion Criteria:

* If a patient developed, during the trial GAL-INT-8, symptoms of other neurological or psychiatric diseases that might contribute to dementia, the subject cannot be enrolled. This includes subjects developing neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, or Creutzfeldt-Jacob disease, and subjects with cognitive impairment resulting from stroke, acute cerebral trauma, hypoxic cerebral damage, infection or primary or metastatic cerebral neoplasia
* Subjects with the following co-existing medical conditions: a) Any history of epilepsy or convulsions except for febrile convulsions during childhood b) Peptic ulcer: if the ulcer is considered to be still "active", i.e., if treatment for this condition started \<3 months ago or if treatment is not successful (symptoms still present), the subject is not eligible. c) Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
* Patients with current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to complete a 12-month trial. The following would usually be considered clinically significant cardiovascular disease: a) Unstable angina
* angina or coronary artery disease that required a change in medication (anti-angina or digitalis) within the last 3 months b) Decompensated congestive heart failure i.e. when symptoms occur in a subject on stable medication during rest or light exercise (NYHA III and IV). Note: if the only signs of decompensation are pretibial or malleolar oedema and the exercise tolerance is still reasonable (absence of dyspnoea) the subject should not be excluded c) Cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status
* In addition, the following conditions should lead to exclusion: atrial fibrillation without prophylactic treatment to prevent thromboembolic stroke, bradycardia \<50 beats/min., atrioventricular block \> first degree. d) Severe mitral or aortic valvular disease e) Hypotension or treatment for hypotension f) Systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg
* Patients using any agent for the treatment of dementia (approved, experimental, including over the counter agents), including, but not limited to nootropic agents, cholinomimetic agents, choline, oestrogens taken without medical need, chronic NSAIDs (30 consecutive days), vitamin E more than 30 IU daily, and deprenyl
* Conditions that could interfere with the absorption of the compound or with the evaluation of the disease

Answer: B