Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001894-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The drug, scopolamine, can result in short-term impairments of cognitive function, attention, and memory that resemble those seen in aging and Alzheimer's disease. This study tested the capability of both individual and combined doses of MK-3134 and the current standard treatment: donepezil (Aricept), to reverse such impairments, following a single dose of scopolamine. Participants were evaluated after each of 5 different treatment periods (in a cross-over, double-dummy design): A: placebo to match both donepezil (oral [PO]) and MK-3134 (PO) followed by placebo scopolamine (subcutaneous [SQ]); B: placebo to match both donepezil (PO) and MK-3134 (PO), followed by scopolamine SQ; C: MK-3134 (PO) followed by scopolamine SQ; D: donepezil (PO) followed by scopolamine SQ; E: MK-3134 (PO) and donepezil (PO) followed by scopolamine SQ. The doses of MK3134, donepezil, and scopolamine were the same over all treatment arms in which the specified drug was administered. There were 8 total visits for each treatment period, including 5 Treatment Visits requiring 14-day intervals between visits for study-drug washout. Participants were assessed for cognitive function before and after each treatment period during the Treatment Visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, B, D, E, C | Experimental | Participants received treatment A, B, D, E, C for Periods 1, 2, 3, 4, and 5, respectively. |
|
| B, C, E, A, D | Experimental | Participants received treatment B, C, E, A, D for Periods 1, 2, 3, 4, and 5, respectively. |
|
| C, D, A, B, E | Experimental | Participants received treatment C, D, A, B, E for Periods 1, 2, 3, 4, and 5, respectively. |
|
| D, E, B, C, A | Experimental | Participants received treatment D, E, B, C, A for Periods 1, 2, 3, 4, and 5, respectively. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine | Drug | Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ. |
| Measure | Description | Time Frame |
|---|---|---|
| CogState Early Phase Battery, Groton Maze Learning Test (GMLT) as measured by the number of errors on the GMLT over time (area under the GMLT-time curve) over hours 1-12. | Participants learned a hidden pathway through a maze (10 x 10 grid of tiles on a computer touch screen) using step-by-step guess, with trial and error feedback after each step. Once the pathway was learned, participants repeated the same pathway four more times. The number of pathway errors was used to indicate the level of cognitive function. | 1, 2, 3, 4, 6, 8, and 12 hours relative to administration of SQ scopolamine or SQ placebo |
Not provided
Not provided
Participants were eligible for inclusion in the study who were:
Participants were not eligible for inclusion in the study if they:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21644059 | Derived | Cho W, Maruff P, Connell J, Gargano C, Calder N, Doran S, Fox-Bosetti S, Hassan A, Renger J, Herman G, Lines C, Verma A. Additive effects of a cholinesterase inhibitor and a histamine inverse agonist on scopolamine deficits in humans. Psychopharmacology (Berl). 2011 Dec;218(3):513-24. doi: 10.1007/s00213-011-2344-y. Epub 2011 Jun 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| E, A, C, D, B | Experimental | Participants received treatment E, A, C, D, B for Periods 1, 2, 3, 4, and 5, respectively. |
|
| A, C, B, E, D | Experimental | Participants received treatment A, C, B, E, D for Periods 1, 2, 3, 4, and 5, respectively. |
|
| B, D, C, A, E | Experimental | Participants received treatment B, D, C, A, E for Periods 1, 2, 3, 4, and 5, respectively. |
|
| C, E, D, B, A | Experimental | Participants received treatment C, E, D, B, A for Periods 1, 2, 3, 4, and 5, respectively. |
|
| D, A, E, C, B | Experimental | Participants received treatment D, A, E, C, B for Periods 1, 2, 3, 4, and 5, respectively. |
|
| E, B, A, D, C | Experimental | Participants received treatment E, B, A, D, C for Periods 1, 2, 3, 4, and 5, respectively. |
|
| B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg | Drug | Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ. |
|
| C: MK-3134 25 mg + Scopolamine 0.5 mg | Drug | A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg. |
|
| D: Donepezil 10 mg + Scopolamine 0.5 mg | Drug | A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ. |
|
|
| E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg | Drug | A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ. |
|
|
| ID | Term |
|---|---|
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| D009410 | Nerve Degeneration |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012601 | Scopolamine |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011083 | Polycyclic Compounds |
Not provided
Not provided