Clinical trial for Attention Deficit Hyperactivity Disorder
Official title Evaluation of Foquest in Adults 65 Years and Older With ADHD
ClinicalTrials.gov ID: NCT07710014
What this study is testing
What is Foquest?
Foquest is an investigational once‑daily extended‑release capsule being studied for attention‑deficit/hyperactivity disorder in adults 65 and older. It is designed to release 20% of the drug immediately and 80% in a delayed fashion to provide sustained symptom control.
Also referred to as Methylphenidate hydrochloride extended‑release.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if Foquest is safe and can reduce ADHD symptoms in people 65 and older. It also looks at how the drug affects thinking skills, overall improvement, and heart health.
- Who it's for
- Adults who are 65 years old or older and have been diagnosed with ADHD.
- What's involved
- Participants will take Foquest once a day for about 10 weeks. The dose starts at 25 mg and can be increased each week up to 100 mg depending on how well they tolerate it. They will have regular visits for check‑ups, blood pressure and heart rate checks, and ECG tests to monitor heart health.
- Time commitment
- The study lasts roughly 10 weeks, with visits for dose adjustments, a 2‑week maintenance period, and a 2‑week follow‑up after stopping the medication.
- Phase 4: studies an already-approved treatment
- Time commitment: about 10 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join 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
You likely can't join 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...
- 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
See the full eligibility 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
- 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)
- History of heart failure, unexplained dyspnea on exertion, or newly identified murmur
- MoCA score less than 26 or evidence of cognitive impairment
- Currently considered a suicide risk in the opinion of the investigator
The study team makes the final eligibility decision.
Where it is enrolling
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ottawa, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.