Evaluation of Foquest in Adults 65 Years and Older With ADHD

NCT07710014 | Not Yet Recruiting Phase 4

• 1 other identifier: MLR-MPH-OLDERADULT-01
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Methylphenidate; Foquest; Geriatric; Extended-Release Stimulant; Attention Deficit Disorder

Outcome Measures

Primary Outcomes (1)

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

  Mean change from baseline (Week 1) to end of treatment (Week 8) in AISRS total score. The AISRS is an 18-item clinician-administered scale aligned with DSM criteria for ADHD, with each item rated 0-3 (total score range 0-54). Higher scores indicate greater symptom severity. Analysis uses a paired t-test in the modified intention-to-treat population.

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

Secondary Outcomes (7)

• Mean Change in ASRS-5 Total Score

  Baseline (Week 1) to Week 8, with interim assessments at Weeks 3 and 5

• Mean Change in Clinical Global Impression - Severity (CGI-S) Score

  Baseline (Week 1) to Week 8

• Clinical Global Impression - Improvement (CGI-I) Responder Rate

  Week 8 (End of Treatment)

• Mean Change in BRIEF-A Global Executive Composite (GEC) T-Score

  Baseline (Week 1) to Week 8

• Change in Systolic Blood Pressure

  Baseline (Week 1) to Week 8, with interim assessments at Weeks 3 and 5

Study Arms (1)

Foquest (Multilayer-Release Methylphenidate)

EXPERIMENTAL

All participants receive open-label Foquest (multilayer-release methylphenidate hydrochloride) once daily, initiated at 25 mg and titrated weekly over 6 weeks to an optimal dose up to a maximum of 100 mg daily, followed by a 2-week maintenance phase and a 2-week follow-up period.

Drug: Methylphenidate hydrochloride extended-release capsules

Interventions

Methylphenidate hydrochloride extended-release capsules DRUG

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

Also known as: Foquest, MLR-MPH

Foquest (Multilayer-Release Methylphenidate)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dar Clinical Research Inc.: lead

Related Publications (7)

• 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.

  PMID: 19281853 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.

  PMID: 34694389 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.

  PMID: 17873677 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.

  PMID: 32508213 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.

  PMID: 18515459 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.

  PMID: 38446477 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.

  PMID: 21192153 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Judy van Stralen, MD, FRCPC

  JPM van Stralen Medicine Professional Corporation / DAR Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy van Stralen, M.D, FRCPC

CONTACT

613-726-7355; judy@cfpe.ca

Doron Almagor, MD, FRCPC

CONTACT

613-726-7355 ext. 101; doron.almagor@possibilitiesclinic.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: All participants receive the same drug; there is no randomization to different arms. This is a within-subject (pre-post) design.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 21, 2027
• Study Completion (Estimated): July 21, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07