A Phase 1 interventional study of A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine and B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg in Dementia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-06.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 31 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Participants were eligible for inclusion in the study who were:
Participants were not eligible for inclusion in the study if they:
Participants received treatment A, B, D, E, C for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Participants received treatment B, C, E, A, D for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Participants received treatment C, D, A, B, E for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Participants received treatment D, E, B, C, A for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Participants received treatment E, A, C, D, B for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Participants received treatment A, C, B, E, D for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Participants received treatment B, D, C, A, E for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Participants received treatment C, E, D, B, A for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Participants received treatment D, A, E, C, B for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Participants received treatment E, B, A, D, C for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine · Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg · Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg · Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg · Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Also known as: Aricept (donepezil)
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Also known as: Aricept (donepezil)
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.
Time frame: 1, 2, 3, 4, 6, 8, and 12 hours relative to administration of SQ scopolamine or SQ placebo
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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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