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Table 2 Review of potential endpoints for consideration

From: Randomized controlled trials in frontotemporal dementia: cognitive and behavioral outcomes

Domain

Test example

Strengths

Limitations

Global

Clinician Interview Based Impression of Change (with caregiver interview)

Evaluates behavior, cognition and functioning; previously used in clinical trials; demonstrated sensitivity to change

Relies on subjective data from caregivers

 

Clinical Dementia Rating

FTD-Specific version available; sensitive to change; association with biomarkers

Reliance on subjective data; lengthy to administer; coarse metric

 

Clinical Global Impressions

Widely used in existing trials in FTD; sensitive to change; individual subscales available

Reliance on subjective data

Composite

Montreal Cognitive Assessment

Brief screen; sensitive to change; multicultural; alternate forms; freely available

Limited use in clinical trials; insufficient coverage of cognitive domains; potential for ceiling effects

 

Repeatable Battery for the Assessment of Neuropsychological Status

Multi-domain assessment; alternate forms available

Inadequate coverage of executive functioning

 

Dementia Rating Scale, 2nd Ed.

Multi-domain assessment sensitive to presence of dementia; previously used in clinical trials

Limited assessment of executive functioning; no alternate form

 

EXAMINER

Developed with FTD in mind; intended for clinical trials; customizable; specific to executive functioning; measures social cognition and behavior

Actual trial performance is to be determined

 

Neuropsychological Test Battery

Proven trial performance; sensitive to change

Relies heavily on memory functioning; no alternate forms

Executive

Trail Making Test

Previously used in clinical trials; extensive normative data; widely used

Limited sensitivity to change in previous trials; prone to floor effects

 

Stroop Test

Multiple variants available; extensive normative data; previously used in clinical trials; relatively immune to ceiling effects

Sensitive to practice effects; interference conditions may be prone to floor effects

 

EXIT-25

Previously used in FTD trials

Longer and more complicated administration than comparable alternatives

 

Frontal Assessment Battery

Brief, simple administration; sensitive to change; multiple language versions

No alternate forms

 

Clock Drawing

Sensitive to executive dysfunction; simple and brief administration; many variants available

Sensitivity and specificity vary as a function of version used.

Language

Boston Diagnostic Aphasia Examination

Sensitive to expressive and receptive language impairments;

Limited use in clinical trials; limited sensitivity to speech abnormalities; no alternate forms; prone to ceiling effects

 

Western Aphasia Battery

Sensitive to expressive language impairments; previous use in clinical trials

limited sensitivity to speech abnormalities; no alternate forms; prone to ceiling effects

 

Controlled Oral Word Association Test

Previously used in trials; sensitive to change

Only one well-validated alternate form; culturally limited

 

Boston Naming Test

Widely used; extensive normative data; some use in trials

Non-normal distribution of scores; no alternate forms; culturally limited

Memory

California Verbal Learning Test, 2nd Ed.

Provides multiple estimates of memory (including learning) and insight into executive functioning

Only one alternate form; lengthy to administer; Recognition trials vulnerable to ceiling effects

 

Rey Auditory Verbal Learning Test

Previously used in clinical trials; provides estimates of learning, recall and recognition

Recognition trials vulnerable to ceiling effects; recall trials vulnerable to floor effects

Visuospatial Functioning

Judgment of Line Orientation

Relatively free from practice effects; minimal demand on motor and language

Vulnerable to ceiling effects; can be lengthy administration

 

Figure Copy tests

Insights into perception, organization and executive functioning; multiple forms

Confounded by motor impairment; scoring can be complex

Behavior

Neuropsychiatric Inventory

Widely used in clinical trials; sensitive to change

Not specific to behavioral changes associated with FTD; large standard variations; Improvements may be related to increasing apathy

 

Frontal Behavior Inventory

Sensitive to change; employed in existing trials

Improvements may be related to increasing apathy

 

Frontal Systems Behavior Examination

Allows for intra-individual comparison; quantification of apathy

Relies on reliable informant