DementiaPhase 1NCT01181310
Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED)
A Phase 1 study testing C: MK-3134 25 mg + Scopolamine 0.5 mg, D: Donepezil 10 mg + Scopolamine 0.5 mg and E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg in people with Dementia, run by Merck Sharp & Dohme LLC.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- C: MK-3134 25 mg + Scopolamine 0.5 mg, D: Donepezil 10 mg + Scopolamine 0.5 mg and E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Oct 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Participants were eligible for inclusion in the study who were:
- 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.
About this study
Official title: A Five-Period, Placebo-Controlled, Crossover Study to Evaluate the Effect of Donepezil and MK-3134 on Reversal of Cognitive Impairment Associated With a Single-Dose of Scopolamine.
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.
- Conditions
- Dementia
- Being tested
- A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine, B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg, C: MK-3134 25 mg + Scopolamine 0.5 mg, D: Donepezil 10 mg + Scopolamine 0.5 mg, E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
- Keywords
- dementia, cognitive impairment, neurodegeneration, Alzheimer's, acetylcholine, AchE
- Medical subject headings
- Dementia, Cognitive Dysfunction, Nerve Degeneration, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: Placebo to match Donepezil and MK-3134 + Placebo to match ScopolamineDrug
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 mgDrug
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 mgDrug
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 mgDrug
Also called Aricept (donepezil)
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 mgDrug
Also called Aricept (donepezil)
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
| Study group | Role | What they receive |
|---|---|---|
| A, B, D, E, C | Experimental | Participants received treatment A, B, D, E, C for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
| B, C, E, A, D | Experimental | Participants received treatment B, C, E, A, D for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
| C, D, A, B, E | Experimental | Participants received treatment C, D, A, B, E for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
| D, E, B, C, A | Experimental | Participants received treatment D, E, B, C, A for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
| E, A, C, D, B | Experimental | Participants received treatment E, A, C, D, B for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
| A, C, B, E, D | Experimental | Participants received treatment A, C, B, E, D for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
| B, D, C, A, E | Experimental | Participants received treatment B, D, C, A, E for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
| C, E, D, B, A | Experimental | Participants received treatment C, E, D, B, A for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
| D, A, E, C, B | Experimental | Participants received treatment D, A, E, C, B for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
| E, B, A, D, C | Experimental | Participants received treatment E, B, A, D, C for Periods 1, 2, 3, 4, and 5, respectively. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 2, 3, 4, 6, 8, and 12 hours relative to administration of SQ scopolamine or SQ placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJun 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181310
- Sponsor's protocol ID
- 3134-005
- Other IDs
- 2007-001894-27
- Status last verified
- Nov 2015
- First submitted
- 12 Aug 2010
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21644059
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Five-Period, Placebo-Controlled, Crossover Study to Evaluate the Effect of Donepezil and MK-3134 on Reversal of Cognitive Impairment Associated With a Single-Dose of Scopolamine.
- ClinicalTrials.gov ID
- NCT01181310
- Acronym / sponsor ID
- 3134-005
- Conditions
- Dementia
- Keywords
- dementia, cognitive impairment, neurodegeneration, Alzheimer's, acetylcholine, AchE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| A, B, D, E, C | Experimental | 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 mgParticipants received treatment A, B, D, E, C for Periods 1, 2, 3, 4, and 5, respectively. |
| B, C, E, A, D | Experimental | 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 mgParticipants received treatment B, C, E, A, D for Periods 1, 2, 3, 4, and 5, respectively. |
| C, D, A, B, E | Experimental | 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 mgParticipants received treatment C, D, A, B, E for Periods 1, 2, 3, 4, and 5, respectively. |
| D, E, B, C, A | Experimental | 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 mgParticipants received treatment D, E, B, C, A for Periods 1, 2, 3, 4, and 5, respectively. |
| E, A, C, D, B | Experimental | 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 mgParticipants received treatment E, A, C, D, B for Periods 1, 2, 3, 4, and 5, respectively. |
| A, C, B, E, D | Experimental | 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 mgParticipants received treatment A, C, B, E, D for Periods 1, 2, 3, 4, and 5, respectively. |
| B, D, C, A, E | Experimental | 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 mgParticipants received treatment B, D, C, A, E for Periods 1, 2, 3, 4, and 5, respectively. |
| C, E, D, B, A | Experimental | 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 mgParticipants received treatment C, E, D, B, A for Periods 1, 2, 3, 4, and 5, respectively. |
| D, A, E, C, B | Experimental | 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 mgParticipants received treatment D, A, E, C, B for Periods 1, 2, 3, 4, and 5, respectively. |
| E, B, A, D, C | Experimental | 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 mgParticipants received treatment E, B, A, D, C for Periods 1, 2, 3, 4, and 5, respectively. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A: Placebo to match Donepezil and MK-3134 + Placebo to match ScopolamineSingle doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ. | Drug | A, B, D, E, C, A, C, B, E, D, B, C, E, A, D, B, D, C, A, E, C, D, A, B, E, C, E, D, B, A, D, A, E, C, B, D, E, B, C, A, E, A, C, D, B, E, B, A, D, C |
| B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mgSingle doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ. | Drug | A, B, D, E, C, A, C, B, E, D, B, C, E, A, D, B, D, C, A, E, C, D, A, B, E, C, E, D, B, A, D, A, E, C, B, D, E, B, C, A, E, A, C, D, B, E, B, A, D, C |
| C: MK-3134 25 mg + Scopolamine 0.5 mgA single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg. | Drug | A, B, D, E, C, A, C, B, E, D, B, C, E, A, D, B, D, C, A, E, C, D, A, B, E, C, E, D, B, A, D, A, E, C, B, D, E, B, C, A, E, A, C, D, B, E, B, A, D, C |
| D: Donepezil 10 mg + Scopolamine 0.5 mgAlso: Aricept (donepezil)A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ. | Drug | A, B, D, E, C, A, C, B, E, D, B, C, E, A, D, B, D, C, A, E, C, D, A, B, E, C, E, D, B, A, D, A, E, C, B, D, E, B, C, A, E, A, C, D, B, E, B, A, D, C |
| E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mgAlso: Aricept (donepezil)A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ. | Drug | A, B, D, E, C, A, C, B, E, D, B, C, E, A, D, B, D, C, A, E, C, D, A, B, E, C, E, D, B, A, D, A, E, C, B, D, E, B, C, A, E, A, C, D, B, E, B, A, D, C |
Primary outcome
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.
Time frame: 1, 2, 3, 4, 6, 8, and 12 hours relative to administration of SQ scopolamine or SQ placebo
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Derived from this study: PubMed 21644059Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C: MK-3134 25 mg + Scopolamine 0.5 mg, D: Donepezil 10 mg + Scopolamine 0.5 mg and E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg in people with Dementia, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1, 2, 3, 4, 6, 8, and 12 hours relative to administration of SQ scopolamine or SQ placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01181310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.