Evaluation of Foquest in Adults 65 Years and Older With ADHD

Summary

This study is evaluating the safety and effectiveness of Foquest (multilayer-release methylphenidate), a once-daily extended-release medication for attention-deficit/hyperactivity disorder (ADHD), in adults aged 65 years and older. ADHD can persist into older age and is associated with reduced quality of life and difficulties with executive function. Foquest is currently approved in Canada for the treatment of ADHD in adults up to age 65, but there is very limited research on its use in older adults. People over 65 may respond differently to stimulant medications due to age-related changes in how the body processes drugs, other medical conditions, and increased sensitivity to cardiovascular side effects. This is an open-label study, meaning all participants will know they are receiving the study medication. There is no placebo group. Participants will take Foquest once daily for approximately 10 weeks, including a 6-week dose adjustment period, a 2-week maintenance period, and a 2-week follow-up period. The dose will start at 25 mg daily and may be increased weekly up to a maximum of 100 mg daily based on how well the participant responds and tolerates the medication. The main goal of the study is to measure changes in ADHD symptoms using a clinician-rated scale called the Adult ADHD Investigator Symptom Rating Scale (AISRS). The study will also assess changes in executive function, overall clinical improvement, and cardiovascular safety measures including blood pressure, heart rate, and electrocardiograms (ECGs). Safety will be closely monitored throughout the study, with enhanced cardiovascular monitoring during the first 6 weeks of treatment.

Timeline

Start

2026-07

Primary completion

2027-07-21

Completion

2027-07-21

Publications

• Background Wakamatsu A, Nomura S, Tate Y, Shimizu S, Harada Y. Effects of methylphenidate hydrochloride on the cardiovascular system in vivo and in vitro: a safety pharmacology study. J Pharmacol Toxicol Methods. 2009 May-Jun;59(3):128-34. doi: 10.1016/j.vascn.2009.01.003. Epub 2009 Mar 9.
• Background Tadrous M, Shakeri A, Chu C, Watt J, Mamdani MM, Juurlink DN, Gomes T. Assessment of Stimulant Use and Cardiovascular Event Risks Among Older Adults. JAMA Netw Open. 2021 Oct 1;4(10):e2130795. doi: 10.1001/jamanetworkopen.2021.30795.
• Background Parasrampuria DA, Schoedel KA, Schuller R, Silber SA, Ciccone PE, Gu J, Sellers EM. Do formulation differences alter abuse liability of methylphenidate? A placebo-controlled, randomized, double-blind, crossover study in recreational drug users. J Clin Psychopharmacol. 2007 Oct;27(5):459-67. doi: 10.1097/jcp.0b013e3181515205.
• Background Michielsen M, Kleef D, Bijlenga D, Zwennes C, Dijkhuizen K, Smulders J, Hazewinkel A, Beekman ATF, Kooij JJS. Response and Side Effects Using Stimulant Medication in Older Adults With ADHD: An Observational Archive Study. J Atten Disord. 2021 Oct;25(12):1712-1719. doi: 10.1177/1087054720925884. Epub 2020 Jun 8.
• Background Godfrey J. Safety of therapeutic methylphenidate in adults: a systematic review of the evidence. J Psychopharmacol. 2009 Mar;23(2):194-205. doi: 10.1177/0269881108089809. Epub 2008 May 30.
• Background Garcia-Argibay M, Burkner PC, Lichtenstein P, Zhang L, D'Onofrio BM, Andell P, Chang Z, Cortese S, Larsson H. Methylphenidate and Short-Term Cardiovascular Risk. JAMA Netw Open. 2024 Mar 4;7(3):e241349. doi: 10.1001/jamanetworkopen.2024.1349.
• Background Adler LA, Orman C, Starr HL, Silber S, Palumbo J, Cooper K, Berwaerts J, Harrison DD. Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study. J Clin Psychopharmacol. 2011 Feb;31(1):108-14. doi: 10.1097/JCP.0b013e318203ea0a.

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Indications