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NCT07710014

PHASE4

Evaluation of Foquest in Adults 65 Years and Older With ADHD

Sponsor: Dar Clinical Research Inc.

View on ClinicalTrials.gov

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.

Official title: Evaluation of Foquest® (Multilayer-Release Methylphenidate) in Adults ≥ 65 Years With ADHD: An Open-Label, Investigator-Initiated Trial

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07

Completion Date

2027-07-21

Last Updated

2026-07-17

Healthy Volunteers

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Methylphenidate hydrochloride extended-release capsules

Once-daily oral extended-release methylphenidate capsule with multilayer-release technology (20% immediate-release outer layer, 80% delayed-release core). Starting dose 25 mg daily, titrated weekly over 6 weeks to optimal dose (maximum 100 mg daily) based on efficacy and tolerability. Capsules taken in the morning, swallowed whole or opened and sprinkled on applesauce or yogurt. Available strengths: 25, 35, 45, 55, 70, 85, and 100 mg. Two-week maintenance at optimal dose followed by 2-week follow

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