Evaluation of Foquest in Adults 65 Years and Older With ADHD

NCT ID
NCT07710014
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 4
Sponsor
Dar Clinical Research Inc.
Conditions
Attention Deficit Hyperactivity Disorder

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 36 participants (Estimated).

What is being studied

  • Drug: Methylphenidate hydrochloride extended-release capsules

Who may be eligible

Ages
65 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

No study locations are listed in the registry data.

Study details

Start date
July 1, 2026
Primary completion date
July 21, 2027
Completion date
July 21, 2027
First posted
July 17, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07710014
Registry last updated
July 17, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07710014 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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