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Alzheimer's DiseasePhase 2NCT01066481

A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

A Phase 2 study testing PF-01913539 5 mg in people with Alzheimer's Disease and Dementia, run by Pfizer.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease, Dementia, Dimebon
What is being tested?
PF-01913539 5 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2010to Apr 2012
Phase
Phase 2
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mild-to-Moderate Alzheimer's disease
  • MMSE score 10-24 inclusive

Who cannot join

  • Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days
  • Complication of other causes of dementia

About this study

Official title: A Phase 2, Multi-Center, Double-Blinded, Placebo-Controlled Safety And Efficacy Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).

Being tested
PF-01913539 5 mg, Placebo
Keywords
Alzheimer's disease, clinical trial, memory loss, investigational drug, neurodegenerative disease, dementia
Medical subject headings
Alzheimer Disease, Dementia, Memory Disorders, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-01913539 5 mgDrug

    PF-01913539 5 mg three times daily for 6 months

  • PF-01913539 5 mgDrug

    PF-01913539 5 mg three times daily for 6 months

  • PlaceboDrug

    Placebo three times daily for 6 months

Study groups in NCT01066481
Study groupRoleWhat they receive
PF-01913539 5 mg three times dailyExperimentalPF-01913539 5 mg three times daily for 6 months
Receives: Drug: PF-01913539 5 mg
PF-01913539 20 mg three times dailyExperimentalPF-01913539 20 mg three times daily for 6 months
Receives: Drug: PF-01913539 5 mg
PlaceboPlacebo comparatorPlacebo three times daily for 6 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.

    Measured: 26 weeks

  2. Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input

    Measured: 26 weeks

Secondary outcomes (6)

  1. Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.

    Measured: 12, 26 weeks

  2. Mean change in Neuropsychiatric Inventory (NPI) score from baseline.

    Measured: 12, 26 weeks

  3. Mean change in Mini-Mental State Examination (MMSE) score from baseline.

    Measured: 6, 12, 18, 26 weeks

  4. Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.

    Measured: 12, 26 weeks

  5. Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis).

    Measured: 12, 26 weeks

  6. Population PK parameters (CL/F, V/F, etc.)

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionMar 2012 (estimated)
  4. Study completionApr 2012 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01066481
Sponsor's protocol ID
B1451010
Status last verified
Jun 2010
First submitted
9 Feb 2010
Last updated
29 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-01913539 5 mg in people with Alzheimer's Disease and Dementia, run by Pfizer.

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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 29 Jun 2010. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 withdrawn before enrolling participants, so there are no results.

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?

Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline. (time frame: 26 weeks). The study lists 2 primary outcomes in all. 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 NCT01066481.

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 29 Jun 2010.

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