Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A, B, D, E, C

Participants received treatment A, B, D, E, C for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

B, C, E, A, D

Participants received treatment B, C, E, A, D for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

C, D, A, B, E

Participants received treatment C, D, A, B, E for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

D, E, B, C, A

Participants received treatment D, E, B, C, A for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

E, A, C, D, B

Participants received treatment E, A, C, D, B for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

A, C, B, E, D

Participants received treatment A, C, B, E, D for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

B, D, C, A, E

Participants received treatment B, D, C, A, E for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

C, E, D, B, A

Participants received treatment C, E, D, B, A for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

D, A, E, C, B

Participants received treatment D, A, E, C, B for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

E, B, A, D, C

Participants received treatment E, B, A, D, C for Periods 1, 2, 3, 4, and 5, respectively.

Group Type EXPERIMENTAL

A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Intervention Type DRUG

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

Interventions

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A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.

Intervention Type DRUG

B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg

Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.

Intervention Type DRUG

C: MK-3134 25 mg + Scopolamine 0.5 mg

A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.

Intervention Type DRUG

D: Donepezil 10 mg + Scopolamine 0.5 mg

A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.

Intervention Type DRUG

E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg

A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.

Intervention Type DRUG

Other Intervention Names

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Aricept (donepezil) Aricept (donepezil)

Eligibility Criteria

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Inclusion Criteria

* Male between 18 and 40 years of age.
* Non-smokers, in good health (as defined in protocol), and were willing to follow study-related procedures.

Participants were not eligible for inclusion in the study if they:

* Had a history of illness that, in the opinion of the study investigator or as specified in protocol, might confound the results of the study or posed an potential, additional risk to the participant if they were to participate in the study.
* Were taking any medication (prescription, nonprescription, vitamin supplements or herbal, illicit or legitimate) except for acetaminophen.
* Had a history of any significant head injury/trauma.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes