Outcome Measures for Dementia With Lewy Body Clinical Trials: A Review

Area of Science:

• Neurology
• Clinical Trials
• Dementia Research

Background:

• Dementia with Lewy bodies (DLB) is a prevalent neurodegenerative disorder.
• The number of clinical trials for DLB is growing, necessitating standardized outcome assessments.
• Identifying effective outcome measures is critical for advancing DLB research and treatment.

Purpose of the Study:

• To identify and categorize the outcome measures utilized in clinical trials for dementia with Lewy bodies.
• To assess the commonality of specific cognitive, behavioral, and motor assessment tools in DLB trials.
• To highlight the need for validated and DLB-specific outcome measures in future research.

Main Methods:

• A comprehensive literature search was conducted on PubMed and clinicaltrials.gov.
• Interventional studies involving DLB populations meeting NIH criteria for clinical trials were included.
• Outcome measures were systematically collected and categorized based on DLB's core and supportive features.

Main Results:

• Fifty-eight DLB clinical trials were identified.
• The Mini Mental State Examination was the most frequent cognitive measure (n=24).
• The Neuropsychiatric Inventory (n=31) and Unified Parkinson's Disease Rating Scale (n=23) were commonly used for behavioral and motor assessments, respectively.

Conclusions:

• Current outcome measures in DLB trials are frequently not validated for this specific population.
• Many existing measures may lack face validity in DLB patients.
• There is an urgent need to validate current scales and develop novel, DLB-specific outcome measures for improved clinical trial rigor.