Not Yet RecruitingPhase 4

Evaluation of Foquest in Adults 65 Years and Older With ADHD

36 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female aged 65 years or older at the time of consent.
. Mentally and physically competent to provide informed consent and willing to comply with the study protocol
. Meets DSM-5 criteria for ADHD combined presentation, inattentive presentation, or hyperactive/impulsive presentation based on clinical history
. SRS-5 score of 14 or greater at screening
. AISRS total score of 24 or greater at baseline
. Montreal Cognitive Assessment (MoCA) score of 26 or greater

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is specifically for adults 65 and older with ADHD, and I'm in that age group, how does my current overall health and any medications I'm already taking affect whether this trial might be a good fit for me to discuss with you?
2Foquest is a stimulant medication — are there particular heart, blood pressure, or other age-related health concerns that would make it especially important to weigh carefully before considering a trial like this one at my age?
3This is a Phase 4 trial, which I understand means the drug is already approved — does that mean more is known about its safety compared to earlier-phase trials, and does that change how you'd think about it as an option for me?
4The trial isn't recruiting yet — is there a currently available standard treatment for ADHD in older adults that might make sense to try now while I wait, or would you recommend holding off?
5The trial measures symptom change using a rating scale called the AISRS — how would you and I know whether my ADHD symptoms are actually improving enough to matter in my day-to-day life, beyond just a score on a scale?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score

Timeframe: Baseline (Week 1) to End of Treatment (Week 8)

Trial details

NCT IDNCT07710014

SponsorDar Clinical Research Inc.

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2027-07-21

Contact for this trial

Judy van Stralen, M.D, FRCPC

613-726-7355 judy@cfpe.ca

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials