International Collaboration for Real-World Evidence in Alzheimer's Disease (ICARE AD)- A Prospective Real-World Observational Study of Aducanumab-avwa in Patients With Alzheimer's Disease in the US

Change from Baseline in Quick Dementia Rating Scale Informant Version & Patient Version (QDRS-IV/PV) Score

时间窗: Up to 5 years

QDRS-IV /PV is rapid dementia staging tool. It is a 10-item questionnaire completed by an informant and a participant. The 10 domains covered are memory and recall, orientation, decision-making and problem-solving abilities, activities outside the home, function at home and hobbies, toileting and personal hygiene, behavior and personality changes, language and communication abilities, mood, and attention and concentration. Each domain is rated on five-point scale with increasing severity of symptoms. Total scores range from 0 to 30 with higher scores representing greater cognitive impairment.

Change from Baseline in 13-Item Quality of Life in Alzheimer's Disease (QoL-AD) Score

时间窗: Up to 5 years

The scale includes 13 items of life domains including the participant's physical health, mood, relationships, activities, and ability to complete tasks. Each item is scored using a scale of 1-4 (poor, fair, good, or excellent). Total score ranges 13-52; higher scores indicate better QOL.

Change from Baseline in Montreal Cognitive Assessment Version 8.1 (MoCA v8.1) Score

时间窗: Up to 5 years

It is used to detect mild cognitive dysfunction. It assesses 30 items in different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score ranges from 0-30 with lower score indicating poor performance.

Change from Baseline in Patient Global Impression of Change (PGI -C) Score

时间窗: Up to 5 years

PGI-C is a 7-point self-administered scale that assesses if there has been a change in the participant's health over time. Participants will rate their change as "1=very much improved," "2=much improved," "3=minimally improved," "4=no change," "5=minimally worse," "6=much worse," or "7=very much worse".

Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score

时间窗: Baseline up to 5 years

The NPI-Q assesses twelve behavioral domains common in dementia including; hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep/night-time behavior change, and appetite/eating change. The questionnaire is given by the clinician to the patient's caregiver who is asked if the behavior described is present in the patient. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale (1 = mild, 2= moderate, and 3= severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme or very severe). The total severity score represents the sum of individual scores and ranges from 0 to 36. The total distress score represents the sum of individual symptom scores and ranges from 0 to 60.

Change from Baseline in Functional Activities Questionnaire (FAQ) Score

时间窗: Up to 5 years

FAQ is a 10-item questionnaire designed to assess independence in participants with Alzheimer's Disease by measuring instrumental activities of daily living. Each question is rated on a 4-point Likert scale (0 = normal to 3 = dependent). Total score ranges from 0 to 30 with higher scores indicating more impairment.

Change from Baseline in Geriatric Depression Scale Short Form (GDS-SF) Score

时间窗: Up to 5 years

This is the screening test for depression in elderly people. The questionnaire contains 15 items. Participants indicate the presence or absence of each symptom. The GDS-SF score is the total number of positive depressive items. Score range is from 0-15. Scores of 0-4 are considered normal, 5-8 indicate mild depression, 9-11 indicate moderate depression and 12-15 indicate severe depression.

Change from Baseline in Short Form 12 Version 2 (SF-12v2) Score

时间窗: Up to 5 years

It is an alternative to Short Form 36 (SF-36®) for use in large surveys of general and specific populations as well as large longitudinal studies of health outcomes. It consists of eight subscale scores (physical functioning \[PF\], role-physical \[RP\], bodily pain \[BP\], general health \[GH\], vitality \[VT\], social functioning \[SF\], role-emotional \[RE\], and mental health \[MH\]). Total score ranges from 0 to 100. Higher scores indicate better health status.

Change from Baseline in Health Care Resource Utilization (HCRU) Using Resource Utilization in Dementia Lite (RUD Lite)

时间窗: Up to 5 years

Measures HCRU among older adults with dementia and their caregivers, and time spent on formal and informal care by caregivers. This questionnaire is not scored, it provides information, such as, hospitalizations, time spent assisting with personal ADLs, time spent supervising the participant, social services.

Change from Baseline in Amsterdam Instrumental Activities of Daily Living Questionnaire Short Version (A-IADL-Q-SV) Score

时间窗: Up to 5 years

A-IADL-Q-SV is used to measure activities of daily living (ADL) in earliest stages of dementia. It consist of 30 items in 7 categories. All items are rated on a five-point scale, ranging from 'no difficulty' to 'unable to perform'. Scoring is based on item response theory (IRT). A-IADL-Q-SV meet all the basic assumptions of IRT scoring, based on a Graded Response Model: (1) Unidimensionality, which implies that one underlying latent trait determines the items; (2) Local independence, meaning the independence of item responses, conditional on the latent trait; and (3) Monotonicity, meaning the probability of endorsing higher item categories as the trait level increases. The IRT latent trait levels are transformed into a 'T-score' with a range from approximately 20 to 80, a mean of 50 and a standard deviation of 10, with higher 'T-scores' indicating better IADL functioning.

Change form Baseline in Patient Global Impressions Scale of Severity (PGI-S) Score

时间窗: Up to 5 years

PGI-S evaluates the severity of participant's condition. PGI -S is a 1-item questionnaire where the response is recorded on a 4-point scale scored as: "normal" (1), "mild" (2), "moderate" (3), or "severe" (4).

Change from Baseline in Zarit Burden Interview (22-Item) Score

时间窗: Up to 5 years

This assesses the level of burden experienced by the principal caregivers of older participants with senile dementia and disabled participants. It consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden.