HealthyPhase 1NCT01345864
Assessment Of The Effects Of Single Doses Of An Investigational Drug, Given Alone Or With Donepezil, On Scopolamine-Induced Changes In Memory And Learning In Healthy Adults
A Phase 1 study of Healthy, run by Pfizer at 1 site in United States.
Trial summary
This study is designed to look at the potential for an investigational drug (PF-04995274, under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to reverse changes in memory and learning/problem solving skills caused by co-administration of a marketed drug called scopolamine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteers; females must be of non-childbearing potential.
- Weight with normal limits for height.
- Willing to comply with study schedule and able to complete 2 practice sessions (pre-study) with computerized memory and learning/problem solving tests.
Who cannot join
- Positive urine drug screen; concurrent use of prescription or over-the-counter (OTC) drugs or dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication.
- Use of medications with significant serotonergic, cholinergic or anticholinergic side effects [SSRIs, pyridostigmine, tricyclic antidepressants, meclizine, oxybutynin]) within 4 weeks of first dose of study drug.
- Glaucoma
- Abnormal electrocardiogram (ECG)
- Treatment with an investigational drug within 30 days of dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Randomized, Double-Blind, Sponsor Unblinded, Placebo- And Positive- Controlled Study To Evaluate The Effects Of Single Oral Administrations Of PF-04995274, Alone Or In Combination With Donepezil, On Scopolamine-Induced Deficits In Psychomotor And Cognitive Function In Healthy Adults
This study is designed to look at the potential for an investigational drug (PF-04995274, under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to reverse changes in memory and learning/problem solving skills caused by co-administration of a marketed drug called scopolamine. Scopolamine is known to cause temporary changes in memory and learning/problem solving skills that are similar to those seen in people with alzheimer's disease(AD).
Read the detailed description
Changes in sponsor's organizational strategy have led to the decision to terminate the study and therefore to not conduct the second cohort (Cohort B/arms 2 and 3) . This decision was not based on significant safety concerns. Date of termination (ie, the date the site was notified to stop study activities) was 12 Oct 2011.
- Conditions
- Healthy
- Being tested
- Scopolamine + Donepezil Placebo + PF-04995274 Placebo, Scopolamine + Donepezil 5 mg + PF-04995274 Placebo, Scopolamine + Donepezil 10mg + PF-04995274 Placebo, Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg, Scopolamine + Donepezil Placebo + PF-04995274 15 mg
- Keywords
- attention cognition memory problem solving scopolamine challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scopolamine + Donepezil Placebo + PF-04995274 PlaceboDrug
Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
Scopolamine + Donepezil 5 mg + PF-04995274 PlaceboDrug
Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 5 mg tablet orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
Scopolamine + Donepezil 10mg + PF-04995274 PlaceboDrug
Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 10 mg (2 x 5 mg tablets) orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
Scopolamine + Donepezil Placebo + PF-04995274 0.25 mgDrug
Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 0.25 mg oral liquid x 1 dose on Day 1
Scopolamine + Donepezil Placebo + PF-04995274 15 mgDrug
Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 15 mg oral liquid x 1 dose on day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Other | Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed. Receives: Drug: Scopolamine + Donepezil Placebo + PF-04995274 Placebo; Drug: Scopolamine + Donepezil 5 mg + PF-04995274 Placebo; Drug: Scopolamine + Donepezil 10mg + PF-04995274 Placebo; Drug: Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg; Drug: Scopolamine + Donepezil Placebo + PF-04995274 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Groton Maze Learning Test (Total Errors)
Measured: Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing
Secondary outcomes (4)
Detection Task (Speed; included in CogState test battery)
Measured: Day 1 of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing
Identification Task (Speed; included in CogState test battery)
Measured: Day of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing
One Card Learning Task (Accuracy of Performance; included in CogState test battery)
Measured: Day 1 of each period at 8 time points from 1-12 hrs postdose relative to scopolamine dosing
Bond-Lader Visual Analogue Scales
Measured: Day 1 of each period at 8 time points from 1-12 hours postdose relative to scopolamine dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionAug 2011
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345864
- Sponsor's protocol ID
- B1661006
- Status last verified
- Nov 2011
- First submitted
- 28 Apr 2011
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Sponsor Unblinded, Placebo- And Positive- Controlled Study To Evaluate The Effects Of Single Oral Administrations Of PF-04995274, Alone Or In Combination With Donepezil, On Scopolamine-Induced Deficits In Psychomotor And Cognitive Function In Healthy Adults
- ClinicalTrials.gov ID
- NCT01345864
- Acronym / sponsor ID
- B1661006
- Conditions
- Healthy
- Keywords
- attention cognition memory problem solving scopolamine challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 May 2011 (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.
This study is designed to look at the potential for an investigational drug (PF-04995274, under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to reverse changes in memory and learning/problem solving skills caused by co-administration of a marketed drug called scopolamine. Scopolamine is known to cause temporary changes in memory and learning/problem solving skills that are similar to those seen in people with alzheimer's disease(AD).
Detailed description
Changes in sponsor's organizational strategy have led to the decision to terminate the study and therefore to not conduct the second cohort (Cohort B/arms 2 and 3) . This decision was not based on significant safety concerns. Date of termination (ie, the date the site was notified to stop study activities) was 12 Oct 2011.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | Drug: Scopolamine + Donepezil Placebo + PF-04995274 Placebo, Drug: Scopolamine + Donepezil 5 mg + PF-04995274 Placebo, Drug: Scopolamine + Donepezil 10mg + PF-04995274 Placebo, Drug: Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg, Drug: Scopolamine + Donepezil Placebo + PF-04995274 15 mgParallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female volunteers; females must be of non-childbearing potential.
- Weight with normal limits for height.
- Willing to comply with study schedule and able to complete 2 practice sessions (pre-study) with computerized memory and learning/problem solving tests.
Key exclusion criteria (5 listed)
- Positive urine drug screen; concurrent use of prescription or over-the-counter (OTC) drugs or dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication.
- Use of medications with significant serotonergic, cholinergic or anticholinergic side effects [SSRIs, pyridostigmine, tricyclic antidepressants, meclizine, oxybutynin]) within 4 weeks of first dose of study drug.
- Glaucoma
- Abnormal electrocardiogram (ECG)
- Treatment with an investigational drug within 30 days of dosing.
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 |
|---|---|---|
| Scopolamine + Donepezil Placebo + PF-04995274 PlaceboScopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1 | Drug | Cohort A |
| Scopolamine + Donepezil 5 mg + PF-04995274 PlaceboScopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 5 mg tablet orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1 | Drug | Cohort A |
| Scopolamine + Donepezil 10mg + PF-04995274 PlaceboScopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 10 mg (2 x 5 mg tablets) orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1 | Drug | Cohort A |
| Scopolamine + Donepezil Placebo + PF-04995274 0.25 mgScopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 0.25 mg oral liquid x 1 dose on Day 1 | Drug | Cohort A |
| Scopolamine + Donepezil Placebo + PF-04995274 15 mgScopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 15 mg oral liquid x 1 dose on day 1 | Drug | Cohort A |
Primary outcome
Groton Maze Learning Test (Total Errors)
Time frame: Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing
4 secondary outcomes
Detection Task (Speed; included in CogState test battery)
Time frame: Day 1 of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing
Identification Task (Speed; included in CogState test battery)
Time frame: Day of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing
One Card Learning Task (Accuracy of Performance; included in CogState test battery)
Time frame: Day 1 of each period at 8 time points from 1-12 hrs postdose relative to scopolamine dosing
Bond-Lader Visual Analogue Scales
Time frame: Day 1 of each period at 8 time points from 1-12 hours postdose relative to scopolamine dosing
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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: stopped early, as of the sponsor's last update on 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
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?
Groton Maze Learning Test (Total Errors) (time frame: Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2011.