Possible or probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria), with Mini-Mental State Exam (MMSE) score of 10-26 inclusive; MMSE scores above 26 in those who nevertheless meet criteria for AD may be allowed with Steering Committee approval on a case by case basis 
Clinically significant apathy for at least four weeks for which either 1) the frequency of apathy as assessed by the Neuropsychiatric Inventory (NPI) is 'Very frequently', or 2) the frequency of apathy as assessed by the NPI is 'Frequently' or 'Often' AND the severity of apathy as assessed by the NPI is 'Moderate' or 'Marked' 
A medication for apathy is appropriate, in the opinion of the study physician 
Provision of informed consent for participation in the study by patient or surrogate (if the patient is unable to provide informed consent) and caregiver 
Availability of primary caregiver, who spends greater than ten hours a week with the patient and supervises his/her care, to accompany the patient to study visits and to participate in the study 
Sufficient fluency, of both the patient and caregiver, in written and spoken English to participate in study visits, physical exams, and outcome assessments 
No change to AD medications within the month preceding randomization, including starting, stopping, or dosage modifications 
Treatment with stable doses of selective serotonin reuptake inhibitor antidepressants(SSRIs) is appropriate if stable for 3 months prior to randomization. Other psychotropics(with the exclusion of antipsychotics), if stable for 3 months, may be allowed only with Steering Committee approval on a case by case basis. 

NCT01117181_inc_T1
Condition
Alzheimer's disease
NCT01117181_inc_T2
Measurement
National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
NCT01117181_inc_T3
Value
probable
NCT01117181_inc_T4
Value
Possible
NCT01117181_inc_T5
Scope
Possible or probable
NCT01117181_inc_T6
Measurement
Mini-Mental State Exam (MMSE)
NCT01117181_inc_T7
Value
score of 10-26 inclusive
NCT01117181_inc_T8
Measurement
MMSE
NCT01117181_inc_T9
Value
scores above 26
NCT01117181_inc_T10
Condition
AD
NCT01117181_inc_T11
Condition
apathy
NCT01117181_inc_T12
Person
at least four weeks
NCT01117181_inc_T13
Measurement
Neuropsychiatric Inventory (NPI)
NCT01117181_inc_T14
Value
Very frequently
NCT01117181_inc_T15
Measurement
NPI
NCT01117181_inc_T16
Value
Frequently
NCT01117181_inc_T17
Value
Often
NCT01117181_inc_T18
Measurement
NPI
NCT01117181_inc_T19
Observation
severity of apathy
NCT01117181_inc_T20
Observation
frequency of apathy
NCT01117181_inc_T21
Scope
'Frequently' or 'Often'
NCT01117181_inc_T22
Value
Moderate
NCT01117181_inc_T23
Value
Marked
NCT01117181_inc_T24
Scope
'Moderate' or 'Marked'
NCT01117181_inc_T25
Scope
frequency of apathy as assessed by the NPI is 'Frequently' or 'Often' AND the severity of apathy as assessed by the NPI is 'Moderate' or 'Marked'
NCT01117181_inc_T26
Observation
frequency of apathy
NCT01117181_inc_T27
Drug
medication for apathy
NCT01117181_inc_T28
Condition
apathy
NCT01117181_inc_T34
Drug
AD medications
NCT01117181_inc_T35
Temporal
within the month preceding randomization
NCT01117181_inc_T36
Reference_point
randomization
NCT01117181_inc_T37
Observation
change to AD medications
NCT01117181_inc_T38
Negation
No
NCT01117181_inc_T39
Drug
selective serotonin reuptake inhibitor antidepressants(SSRIs)
NCT01117181_inc_T40
Qualifier
stable doses
NCT01117181_inc_T41
Procedure
Treatment