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MK0249 · 3 trials · 3 indications
The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.
The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.
The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.
| Arm | Type | Description |
|---|---|---|
| MK0249 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| MK-0249 | EXPERIMENTAL | Total time in the study will be \~10 weeks. |
| Concerta | ACTIVE_COMPARATOR | Total time in the study will be \~10 weeks. |
| Name | Type | Description |
|---|---|---|
| MK0249 | DRUG | MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days. |
| Comparator: Placebo (unspecified) | DRUG | MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period. |
| Concerta (methylphenidate) | DRUG | Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily. |
| Placebo | DRUG | For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily. |
Inclusion Criteria: * Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months * Patient has a 6th grade reading level or better * Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth...
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MK0249 is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK) for neurological conditions. It has been studied in Phase 2 clinical trials for Alzheimer's disease, attention-deficit/hyperactivity disorder (ADHD), and paranoid schizophrenia. It is not an approved therapy and remains in clinical development.
MK0249 targets HRH3, the histamine H3 receptor, and acts as an inverse agonist. By binding this receptor, the drug is designed to modulate histaminergic signaling in the central nervous system. This target class is of interest for cognitive and neuropsychiatric conditions, which is why MK0249 was studied across several neurological indications.
MK0249 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 2 clinical program evaluating the compound in Alzheimer's disease, ADHD, and paranoid schizophrenia. The drug is an internal Merck asset rather than a partnered or licensed program.
MK0249 is in Phase 2 development. All three of its recorded clinical trials were Phase 2 studies, and all have been completed. No active trials are currently listed for MK0249, and the compound is investigational rather than approved for any indication.
MK0249 has been evaluated in three completed Phase 2 trials. NCT00420420 studied it for symptomatic treatment of Alzheimer's disease in 144 patients. NCT00475735 tested safety and efficacy in ADHD in 72 patients. NCT00506077 examined cognitive impairment in patients with schizophrenia in 55 patients.
MK0249 has been studied for Alzheimer's disease, attention-deficit/hyperactivity disorder (ADHD), and paranoid schizophrenia. These were Phase 2 investigations, and the compound is not approved for any of these uses. Its trials were randomized, double-blind, and placebo-controlled.