Foquest in older adults with ADHD: daily methylphenidate for 65+

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase IV, open-label study to evaluate the safety and effectiveness of multilayer-release methylphenidate (Foquest) in adults aged 65 years and older with ADHD. Participants start at 25 mg daily (adjustable up to 100 mg) and are followed for about 10 weeks, including a 6-week dose-titration, 2-week maintenance, and 2-week follow-up, with in-person and phone visits. The trial emphasizes cardiovascular monitoring due to age-related risks and guideline-based screening. It uses a within-subject design to assess changes from baseline on ADHD symptoms and functional measures. No placebo group is used, and all participants receive the study medication.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Satisfied with current ADHD treatment
2. History of myocardial infarction, arrhythmia, or congenital heart disease
3. Mean systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg measured in triplicate at screening despite treatment
4. Treated hypertension not stable on medication or with dose changes in the last 30 days
5. History of transient ischemic attack or stroke
6. Current or lifetime DSM-5 diagnosis of bipolar I or II disorder, cyclothymic disorder, or bipolar disorder not otherwise specified
7. Clinical history strongly suggestive of undiagnosed bipolar spectrum disorder
8. Active suicidal ideation or behavior per C-SSRS at screening
9. Current substance use disorder
10. History of drug or alcohol abuse in the last 10 years as defined by DSM-5 criteria for substance use disorder (moderate or severe)
11. True allergy to methylphenidate, history of serious adverse reactions to methylphenidate, or known non-response to methylphenidate
12. History of seizure disorder other than a single childhood febrile seizure before age 3
13. History of glaucoma, hyperthyroidism, thyrotoxicosis, advanced arteriosclerosis, or severe renal insufficiency (eGFR less than 30 mL/min/1.73 m²)
14. Use of a monoamine oxidase inhibitor currently or within the past 14 days
15. Abnormal baseline ECG including left ventricular hypertrophy or QTc greater than 450 ms (males) or greater than 470 ms (females)
16. History of heart failure, unexplained dyspnea on exertion, or newly identified murmur
17. MoCA score less than 26 or evidence of cognitive impairment
18. Currently considered a suicide risk in the opinion of the investigator

Where it's running

• DAR Clinical Research Inc.
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Judy van Stralen, MD, FRCPC — JPM van Stralen Medicine Professional Corporation / DAR Clinical Research
• Study coordinator: Judy van Stralen, M.D, FRCPC
• Email: judy@cfpe.ca
• Phone: 613-726-7355

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.