Cognitive safety

These batteries are designed for use in clinical trials aiming to assess cognition as a safety measure. They provide a broad overview of cognition by tapping into some of the key cognitive domains. Additionally, these tests have been shown to be sensitive to cognitive decline by pharmacological interventions, confirming their suitability for use in these trials to flag any potentially negative effects on cognition as soon as possible. The two batteries (Phase I and II) are similar, with the Phase II battery including one extra test due to the decreased number of testing time points typically seen in these trials, thereby allowing for a greater total battery time.

Phase I

Measures:

• Processing speed
• Visual memory
• Working memory
• Executive Function

CANTAB Tests

• Reaction Time (RTI)
• Paired Associates Learning (PAL)
• Spatial Working Memory (SWM)

The three tests within our Phase I battery have excellent psychometric properties, with test-retest reliabilities of 0.82 for processing speed, 0.7 for visual memory and reaction time, and 0.85 for working memory and executive function. The test panel is sensitive to acute pharmacologically induced cognitive impairment in healthy subjects.

Phase II

Measures:

• Processing speed
• Psychomotor speed
• Sustained attention
• Visual episodic memory
• Working memory
• Executive Function

CANTAB Tests

• Reaction Time (RTI)
• Paired Associates Learning (PAL)
• Spatial Working Memory (SWM)
• Rapid Visual Information Processing (RVP)

Research 

Key references

Food Drug Administration Center for Drugs Evaluation Research (2005). Review Guidance: Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review, FDA Maryland 

Roiser JP, Nathan PJ, Mander AP, Adusei G Zavitz KH, Blackwell AD. Assessment of cognitive safety in clinical drug development. Drug Discov Today. 2016 Mar;21(3):445-53.

Blackwell AD. Measuring cognitive effects: cognition in drug development and repositioning. Drug Discov Today. 2015 Apr;20(4):391-2

Koontz J., Baskys A., (2005) Effects of galantamine on working memory and global functioning in patients with mild cognitive impairment: A double-blind placebo-controlled study, American Journal of Alzheimer’s Disease and Other Dementias, 20(5), 295-302

Randall D.C., Viswanath A., Bharania P., Elsabagh S., Hartley D.E., Shneerson J.M., File S.E., (2005) Does Modafinil enhance cognitive performance in young volunteers who are not sleep deprived, Journal of Clinical Psychopharmacology, 25(2), 175-179

Mehta M.A., Sahakian B.J., McKenna P.J., Robbins T.W., (1999) Systemic sulpiride in young adult volunteers simulates the profile of cognitive deficits in Parkinson’s disease, Psychopharmacology, 146, 162-174