Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
|
6 months |
|
Primary |
Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
|
6 months |
|
Primary |
Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
|
6 months |
|
Primary |
Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE) |
|
6 months |
|
Secondary |
Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) |
The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at the site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment. |
6 months |
|
Secondary |
Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB) |
The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment. |
6 months |
|
Secondary |
Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe) |
The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration. |
6 months |
|
Secondary |
Mini Mental State Examination (MMSE) |
The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function. |
6 months |
|
Secondary |
Neuropsychiatric Inventory (NPI) Score |
The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment. |
6 months |
|
Secondary |
Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) |
The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life. |
6 months |
|
Secondary |
EQ-5D Questionnaire (Proxy Version) |
EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state [100] to worst imaginable health state [0]. Caregivers are asked to describe how they believe a participant would rate his/her health state that day. |
6 months |
|
Secondary |
Healthcare Resource Utilization Questionnaire (HRUQ) |
The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores. |
6 months |
|
Secondary |
Caregiver Burden Questionnaire |
The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden. |
6 months |
|
Secondary |
Time to Skilled Nursing Facility Placement |
Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement. |
6 months |
|
Secondary |
Volumetric MRI |
Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning. |
6 months |
|