Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for caregivers. Alternatives are sorely needed to the currently available sleep medications that have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep in normal older people. Melatonin also may help sleep disturbances associated with AD; however, this remains to be proven.


Options:
A: Inclusion Criteria:

* Patients must meet NINCDS-ADRDA criteria for probable Alzheimer's disease (AD). Patients must have disrupted sleep, documented by clinical history and by 1 to 2 weeks of recording using wrist activity monitors.
* A diagnosis of probable AD.
* MMSE score 0-26.
* Hachinski Ischemia Scale score less than or equal to 4.
* A 2-week history of two or more sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver on the Sleep Disorder Inventory.
* CT or MRI since the onset of memory problems showing no more than one lacunar infarct in a non-strategic area and no clinical events suggestive of stroke or other intracranial disease since the CT or MRI.
* Physically acceptable for study as confirmed by medical history and exam, clinical laboratory results, and EKG.
* Actigraph evidence of a mean nocturnal sleep time of less than 7 hours per night (at least 5 nights of complete actigraph data must be collected over a single week.
* Stable home situation with no planned move during the 13-week investigational period.
* Residing with responsible spouse, family member, or professional caregiver who is present during the night and will agree to assume the role of the principal caregiver for the 13-week protocol, including arranging transport for the patient to and from the investigators' clinic, answering questions regarding the patient's condition, and assuming responsibility for medication and actigraph procedures.
* Ability to ingest oral medication and participate in all scheduled evaluations.
* Six grades of education or work history sufficient to exclude mental retardation.
* 55 years of age or older.
* Hamilton Depression Rating Scale score of 15 or less.
* Stable medication (dose and type) for non-excluded concurrent medical conditions for 4 weeks prior to the screening visit.

Exclusion Criteria:

* Sleep disturbance is acute (within the last 2 weeks).
* Sleep disturbance is associated with an acute illness with delirium.
* Clinically significant movement disorder that would interfere with the actigraph readings.
* Not having a mobile upper extremity to which to attach an actigraph.
* Severe agitation.
* Pain syndrome affecting sleep.
* Unstable medical condition.
* Use of investigational or unapproved medications within 4 weeks of the screening visit.
* Patient unwilling to maintain caffeine abstinence after 2:00 pm for the duration of the protocol.
* Patient unwilling to comply with the maximum limit of two alcoholic drinks per day, and only one alcoholic drink after 6:00 pm for the duration of the protocol.
* Use of melatonin within 2 weeks of screening visit.
* Clinically significant abnormal laboratory findings that have not been approved by the Project Director.
* Residing in a facility without a consistent caregiver present during the night who can function as the primary informant.
* Caregiver deemed too unreliable to supervise the wearing of the actigraph, to maintain the sleep diary, or to bring the patient to the scheduled visits.
* Autoimmune disease, such as rheumatoid arthritis and polymyalgia rheumatica.
B: Inclusion Criteria:

* Age between 60-99 years
* Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia
* Only subjects with Mini Mental Status Examination scores of greater or equal to 10 will be enrolled.

Exclusion Criteria:

1. Subjects who are too agitated to be able to wear the activity monitors;
2. Subjects who are actively suicidal or homicidal or for whom the clinical treatment team considers participation in the study to be unsuitable;
3. Subjects with untreated primary sleep disorders;
4. Subjects who receive hypnotic medications during their participation in the study; Subjects who received hypnotic medications prior to enrollment may participate in the study if they agree to stop receiving hypnotic medications (with their attending physician's approval);
5. Subjects who are receiving over the counter sleep aids;
6. Subjects who can not commit to abstaining from alcohol use while in the study;
7. Subjects with known anaphylactic reaction or angioedema with Zolpidem CR.
C: Inclusion Criteria:

* mild to moderate Alzheimer's disease and related dementia (ADRD)

Exclusion Criteria:

* major organ failure,
* major illness,
* history of head injury,
* hypertension or diabetes,
* use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness
D: Inclusion Criteria:

* Aged \>=55 years
* Clinical Dementia Rating (CDR) score of 0.5-3, indicating very mild to severe dementia
* Physician diagnosis of dementia of the Alzheimer's type
* Nighttime agitation, defined as Cohen Mansfield Agitation Inventory, Direct Observation total score \>=35
* Opinion of the participant's physician that medication for agitation is appropriate
* RLS diagnosis by study advanced practice nurse (APN) or registered nurse (RN) (in consult with the participant's physician, and the investigators), using the Behavioral Indicators Test-Restless Legs
* Medically stable, defined as unchanged medications within 14 days and the absence of fever or other signs and symptoms of acute illness or delirium (e.g. urinary tract infection, pneumonia) that may cause agitation or interfere with the study protocol
* Able to swallow medication
* Ambulatory, with and without assistance
* If currently being treated for RLS, may be included if still having RLS symptoms/signs and confirmed as appropriate for inclusion by medical review

Exclusion Criteria:

* Received \>= 50 morphine milligram equivalents per day (MME/d) in the 14 days prior to the randomization decision, because morphine and GEn taken together have a higher incidence of sedation and dizziness than either drug alone
* Currently being treated for RLS with gabapentin or GEn
* Diagnosis of Parkinson's disease (PD) or any other disorder causing tremor because extrapyramidal symptoms may confound RLS diagnosis and actigraphy
* Receiving gabapentin
* Severe psychosis
* Alcohol consumption because combining alcohol and GEn may increase sedation and other adverse events
* Treatment with GEn is contraindicated, such as when a potential participant is receiving multiple antiepileptic drugs, in the opinion of the study APN or RN, participant's physician, or study medical team
* Failure of past treatment with gabapentin or GEn
* Compromised renal function as indicated by creatinine clearance \<15 or on hemodialysis
* Current participation in a clinical trial or in any study that may affect study outcomes
* Determined to be at risk for suicide by the study APN, RN, or participant's physician
* Any condition, that in the opinion of the study APN or RN, participant's physician, or study medical team, makes it medically inappropriate for the patient to enroll in the trial
* Persons living independently in the community without a live-in caregiver (family or hired)

Answer: A