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Alzheimer DiseasePhase 2/3NCT00277810

Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease

A Phase 2/3 study testing lecozotan SR (SRA-333) in people with Alzheimer Disease, run by Pfizer at 83 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's disease (AD). 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 (SRA-333)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
83 sitesin 11 countries
Study dates
Mar 2006to Jun 2008
Phase
Phase 2/3
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 Alzheimer's disease
  • Current use of cholinesterase inhibitor
  • Able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at least daily for duration of the study

Who cannot join

  • Significant neurological disease other than AD
  • Diagnosis of major depression
  • History of stroke or other heart disease

Trial locations and contacts

83 sites in 11 countries.

83 sites in 11 countries

United States33 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Bennington, Vermont, 05201

  • 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, 33216

  • Study site

    La Jolla, California, 92037

  • Study site

    Long Branch, New Jersey, 07740

  • Study site

    Manchester Twp., New Jersey, 08759

  • Study site

    Memphis, Tennessee, 38119

  • 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

    South Miami, Florida, 33143

  • 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

Other trials in United States

Argentina9 sites

  • Study site

    Av. Belgrano, 2945

  • Study site

    Buenos Aires

  • 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, 950

  • Study site

    Puerto Galván, 4102

Other trials in Argentina

Poland7 sites

  • Study site

    Gdansk - Wrzeszcz, 00-282

  • Study site

    Krakow, 30-393

  • Study site

    Krakow, 31-530

  • Study site

    Lodz, 92-216

  • Study site

    Lublin, 20-022

  • Study site

    Sopot, 81-824

  • Study site

    Szczecin, 70-356

Other trials in Poland

Spain6 sites

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08014

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08036

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28046

Other trials in Spain

Australia5 sites

  • Study site

    Adelaide, 5000

  • Study site

    East Gosford, 2250

  • Study site

    Hornsby, 2077

  • Study site

    Randwick, 2031

  • Study site

    Victoria, 3081

Other trials in Australia

Canada5 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, H4H 1R3

  • Study site

    Ottawa, Ontario, K1N 5C8

Other trials in Canada

United Kingdom5 sites

  • Study site

    Belfast, BT9 7BL

  • Study site

    Glasgow, G20 0XA

  • Study site

    Sheffield, S35 8QS

  • Study site

    Southampton, SO30 3JB

  • Study site

    Swindon, SN1 4JU

Other trials in United Kingdom

France4 sites

  • Study site

    Bordeaux, 33076

  • Study site

    Montpellier, 34295

  • Study site

    Nice, 06002

  • Study site

    Toulouse, 31300

Other trials in France

South Africa4 sites

  • Study site

    Bloemfontein, 9301

  • Study site

    Cape Town, 7500

  • Study site

    Johannesburg, 2197

  • Study site

    Somerset West, 7130

Other trials in South Africa

Finland3 sites

  • Study site

    Helsinki, 00120

  • Study site

    Joensuu, 80100

  • Study site

    Kuopio, 70211

Other trials in Finland

Italy2 sites

  • Study site

    Roma, 00143

  • Study site

    Roma, 00168

Other trials in Italy

About this study

Official title: A 6-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 Treated With a Cholinesterase Inhibitor

The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's disease (AD).

Being tested
lecozotan SR (SRA-333)
Keywords
Alzheimer's Disease, Cholinesterase Inhibitors, Outpatients
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 SR (SRA-333)Drug

    one of 3 doses of lecozotan sr dose for 6 months as an extension to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr

Study groups in NCT00277810
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: lecozotan SR (SRA-333)
BExperimentalNot described
Receives: Drug: lecozotan SR (SRA-333)
CExperimentalNot described
Receives: Drug: lecozotan SR (SRA-333)

What is being measured

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

  1. All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales

    Measured: 6 mo extension study: week 24

Secondary outcomes (1)

  1. Score change from baseline to 24 weeks on functional and behavioral scales

    Measured: week 24

Timeline

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

  1. First posted16 Jan 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionJun 2008
  4. Study completionJun 2008

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00277810
Sponsor's protocol ID
3098B1-203, 3098B1-204
Status last verified
Jul 2020
First submitted
12 Jan 2006
Last updated
7 Jul 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing lecozotan SR (SRA-333) in people with Alzheimer Disease, run by Pfizer at 83 sites in 11 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 3 inclusion and 3 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Argentina, Poland, Spain, Australia and 6 more countries. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales (time frame: 6 mo extension study: week 24). 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 NCT00277810.

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 7 Jul 2020.

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