The Montreal Cognitive Assessment (MoCA): Considerations for Use as a Clinical Trial Endpoint in Alzheimer’s Disease

January 23, 2026

Contributors:
Kaycee Sink, MD, MAS (Chief Medical Officer)
Svenja Wacker, PhD (Neuropsychology Science Director) 


The Montreal Cognitive Assessment (MoCA) is a performance-based cognitive measure widely used to support the detection of mild cognitive impairment and early-stage dementia, including Alzheimer’s disease (AD) and other neurodegenerative conditions. Developed in 1995 and published in 2005 by Nasreddine et al., the MoCA is often used as a screening tool and can be especially useful in trials of preclinical and early symptomatic AD, when cognitive symptoms are mild and more difficult to detect. It can also be useful when tracking changes in cognition over time in preclinical and early AD. 

The MoCA is administered by a trained rater or clinician who observes the participants as they conduct a structured set of tasks. These tasks evaluate seven cognitive domains including visuospatial/executive functioning, naming, short-term/delayed recall memory, attention, concentration, and working memory, language, abstraction, and orientation.  

As the landscape of AD research increasingly emphasizes early intervention and biomarker-driven trial design, sensitive cognitive measures have become essential for identifying subtle changes that traditional assessments may miss. Drawing from extensive experience in global Alzheimer’s disease clinical trials, Cogstate experts provide an informed perspective on how and when the MoCA can be optimally leveraged. 

Advantages of the MoCA  

Utilizing the MoCA as an endpoint in AD trials offers several advantages. The scale is validated as a quantifiable measure of cognition and correlated with biomarkers and other clinical outcome assessments. In addition, its brief 10–15-minute administration time makes it a practical tool in clinical and research contexts as it reduces both participant and administrator burden.   

“Compared to other common screening assessments, the MoCA’s sensitivity makes it a highly effective tool for detecting early cognitive impairment,” says Svenja Wacker, PhD, Neuropsychology Director at Cogstate. “Due to its broad domain coverage including areas like executive function, it provides a more comprehensive evaluation than other endpoint assessments.” 

Furthermore, the MoCA is appropriate for diverse patient populations, with availability in more than 100 languages and cultural adaptations and with versions for hearing or visual impairments, including options for phone interviews. Because of its availability and accessibility, the MoCA is suitable for remote administration, albeit with modifications. 

Considerations of the MoCA as a Trial Endpoint 

While the MoCA has its strengths as an endpoint, there are also some important things clinical research teams should consider prior to leveraging the tool in an AD trial.  

“Although the MoCA is not as lengthy or complex as other standard cognitive assessments, great care must still be taken in rater selection, training, and monitoring,” says Wacker. “Raters must be calibrated on the use of the MoCA to ensure high quality data collection and avoid errors in administration.” 

In addition, Wacker notes that the MoCA lacks specificity in differentiating AD type cognitive deficits from other types of cognitive deficits. The MoCA is particularly sensitive to early Alzheimer’s disease, but its usefulness declines in advanced dementia due to floor effects, which limits its ability to capture further changes. 

The MoCA as an Endpoint in Clinical Trials 

As Alzheimer’s disease research continues to prioritize earlier and more precise detection of cognitive change, the MoCA remains a valuable and versatile tool. Its sensitivity, broad domain coverage, and ease of administration make it well suited for identifying subtle impairments and supporting diverse trial populations. However, thoughtful rater training and awareness of the measure’s limitations, particularly its reduced utility in later-stage dementia, are essential for ensuring high-quality and reliable data.  

  • This blog is part of a series exploring the individual scales reviewed in our Alzheimer’s Disease Clinical Trial Endpoint Guide. Access the full guide here. 
  • Interested in learning more? We are happy to discuss endpoint selection with your team in more depth. Contact us today. 

Sources

* Nasreddine, Z.S., Phillips, N.A., Bédirian, V., Charbonneau, S., Whitehead, V., Collin, I., Cummings, J.L., & Chertkow, H., “The Montreal Cognitive Assessment, MoCA: A brief screening tool for mild cognitive impairment,” Journal of the American Geriatrics Society, (2005). 

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