Could a once-daily ADHD pill work for seniors? new study investigates

NCT ID NCT07710014

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether Foquest, a once-daily extended-release methylphenidate capsule, is safe and effective for treating ADHD in adults aged 65 and older. Participants take the medication for about 10 weeks, starting at 25 mg and adjusting up to 100 mg based on response. The main goal is to see if ADHD symptoms improve, while closely monitoring heart-related safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylphenidate hydrochloride extended-release capsules (Foquest)
What this could lead to
If successful, this could provide a safe and effective treatment option for ADHD in older adults, an age group with very limited research.
What could go wrong
This is a small, open-label study with no placebo group, so results may be biased. Older adults may be more sensitive to cardiovascular side effects like high blood pressure or heart rate changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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