Evaluation of Foquest in Adults 65 Years and Older With ADHD
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorDar Clinical Research Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Methylphenidate hydrochloride extended-release capsules
DrugOnce-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
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Foquest (Multilayer-Release Methylphenidate)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (Week 1) to End of Treatment (Week 8)Secondary outcomes
1
Mean Change in ASRS-5 Total Score
Mean change from baseline to Week 8 in the Adult ADHD Self-Report Scale version 1.1 (ASRS-5) total score. The ASRS-5 is an 18-item self-report questionnaire with Part A (Inattention) and Part B (Hyperactivity/Impulsivity), items rated 0 (Never) to 4 (Very Often). Analyzed using paired t-test and repeated-measures ANOVA across post-baseline timepoints (Weeks 3, 5, and 8).
Time frame
Baseline (Week 1) to Week 8, with interim assessments at Weeks 3 and 52
Mean Change in Clinical Global Impression - Severity (CGI-S) Score
Mean change from baseline to Week 8 in CGI-S score. The CGI-S is a 7-point clinician-rated scale of overall illness severity (1 = Normal, not at all ill; 7 = Among the most extremely ill patients). A responder analysis will report the proportion of participants achieving CGI-S score of 3 or less (mildly ill or better) at Week 8.
Time frame
Baseline (Week 1) to Week 83
Clinical Global Impression - Improvement (CGI-I) Responder Rate
Distribution of CGI-I scores at Week 8. The CGI-I is a 7-point clinician-rated scale evaluating change from baseline (1 = Very much improved; 7 = Very much worse). The clinical responder rate is defined as the proportion of participants rated as much improved or very much improved (CGI-I score of 2 or less) at Week 8, reported with 95% exact binomial confidence intervals.
Time frame
Week 8 (End of Treatment)4
Mean Change in BRIEF-A Global Executive Composite (GEC) T-Score
Mean change from baseline to Week 8 in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite T-score. The BRIEF-A is a 75-item self-report measure of executive functioning in adults aged 18-90, producing norm-referenced T-scores. Higher scores indicate greater executive dysfunction. Individual index scores (Behavioral Regulation Index, Metacognition Index) will also be analyzed.
Time frame
Baseline (Week 1) to Week 8Sponsors and contacts
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Source ClinicalTrials.gov