Alzheimer DiseasePhase 2NCT00151398
Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
A Phase 2 study testing lecozotan SR and Donepezil in people with Alzheimer Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 56 sites in 5 countries.
Trial summary
The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- lecozotan SR and Donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 56 sitesin 5 countries
- Study dates
- 6 Oct 2005to 15 Mar 2008
- 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
- Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
- Able to give informed consent. Patient' s caregiver must consent to participate in the study.
Who cannot join
- Use of medications for cognitive enhancement within 3 months of baseline.
- Significant neurologic disease other than AD that may affect cognition.
Trial locations and contacts
56 sites in 5 countries.
56 sites in 5 countries
United States35 sites
Study site
Albany, New York, 12208
Study site
Bennington, Vermont, 05201
Study site
Boca Raton, Florida, 33486
Study site
Cedarhurst, New York, 11516
Study site
Columbus, Ohio, 43210
Study site
Costa Mesa, California, 92626
Study site
Delray Beach, Florida, 33445
Study site
East Providence, Rhode Island, 02914
Study site
Fort Lauderdale, Florida, 33321
Study site
Fort Myers, Florida, 33916
Study site
Fresno, California, 93720
Study site
Hallandale, Florida, 33009
Study site
Hialeah, Florida, 33016
Study site
Houston, Texas, 77030
Study site
Jacksonville, Florida, 32216
Study site
La Jolla, California, 92037
Study site
Lawrence, New York, 11559
Study site
Long Branch, New Jersey, 07740
Study site
Manchester Twp., New Jersey, 08759
Study site
Memphis, Tennessee, 38119
Study site
Miami, Florida, 33173
Study site
Miami, Florida, 33176
Study site
Miami Beach, Florida, 33154
Study site
Orange, California, 92868
Study site
Orlando, Florida, 32806
Study site
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arizona, 85013
Study site
Sarasota, Florida, 34239
Study site
St Louis, Missouri, 63104
Study site
Staten Island, New York, 10312
Study site
Tampa, Florida, 33617
Study site
Tucson, Arizona, 85741
Study site
Tulsa, Oklahoma, 74104
Study site
West Palm Beach, Florida, 33407
Study site
Winston-Salem, North Carolina, 27103
Argentina8 sites
Study site
Av. Belgrano, 2945
Study site
Calle Adolfo Alsina, 2184
Study site
Cervino, 3356
Study site
Gascon, 450
Study site
Larrea, 1035
Study site
Nueva York, 3952
Study site
Pilar
Study site
Puerto Galván, 4102
Canada6 sites
Study site
Edmonton, Alberta, T5G 0B7
Study site
Medicine Hat, Alberta, T1A 4C2
Study site
Moncton, New Brunswick, E1C 4B7
Study site
Montreal, Quebec
Study site
Ottawa, Ontario, K1N 5C8
Study site
Regina, Saskatchewan, S4T 1A5
South Africa5 sites
Study site
Bellville, Western Cape, 7530
Study site
Florida, Johannesburg, 1709
Study site
Observatory, Cape Town, 7925
Study site
Panorama, Cape Town, 7500
Study site
Westdene, Bloemfontein, 9301
Australia2 sites
Study site
Heidelberg Heights, Victoria, 3081
Study site
Hornsby, New South Wales, 2077
About this study
Official title: A 3-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study Of 3 Doses Of Lecozotan (SRA-333) SR In Outpatients With Mild To Moderate Alzheimer's Disease With Donepezil As Active Control.
The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.
- Conditions
- Alzheimer Disease
- Being tested
- lecozotan SR, Donepezil
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lecozotan SRDrug
evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks.
Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil.
DonepezilDrug
10 mg donepezil QD dosed up to 40 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: lecozotan SR |
| B | Experimental | Not described Receives: Drug: lecozotan SR |
| C | Experimental | Not described Receives: Drug: lecozotan SR |
| D | Active comparator | Not described Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
Measured: weeks 12, 14, 26 and 40.
Secondary outcomes (1)
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
Measured: weeks 12, 14, 26 and 40.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study start6 Oct 2005
- Primary completion15 Mar 2008
- Study completion15 Mar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151398
- Sponsor's protocol ID
- 3098B1-201, 3098B1-202
- Other IDs
- B343-1057, B343-1058
- Status last verified
- Apr 2022
- First submitted
- 6 Sep 2005
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study Of 3 Doses Of Lecozotan (SRA-333) SR In Outpatients With Mild To Moderate Alzheimer's Disease With Donepezil As Active Control.
- ClinicalTrials.gov ID
- NCT00151398
- Acronym / sponsor ID
- 3098B1-201, 3098B1-202
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2005 (actual)
- Primary completion
- 15 Mar 2008 (actual)
- Study completion
- 15 Mar 2008 (actual)
- First posted
- 8 Sep 2005 (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 purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: lecozotan SR |
| B | Experimental | Drug: lecozotan SR |
| C | Experimental | Drug: lecozotan SR |
| D | Active comparator | Drug: Donepezil |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
- Able to give informed consent. Patient' s caregiver must consent to participate in the study.
Key exclusion criteria (2 listed)
- Use of medications for cognitive enhancement within 3 months of baseline.
- Significant neurologic disease other than AD that may affect cognition.
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 |
|---|---|---|
| lecozotan SRevaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil. | Drug | A, B, C |
| Donepezil10 mg donepezil QD dosed up to 40 weeks | Drug | D |
Primary outcome
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
Time frame: weeks 12, 14, 26 and 40.
1 secondary outcome
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
Time frame: weeks 12, 14, 26 and 40.
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 May 2022.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
56 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lecozotan SR and Donepezil in people with Alzheimer Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 56 sites in 5 countries.
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: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Argentina, Canada, South Africa, Australia. 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 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 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?
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score. (time frame: weeks 12, 14, 26 and 40.). 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 6 May 2022.