NCT00277810

Brief 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).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2 alzheimer-disease

Timeline
Completed

Started Mar 2006

Geographic Reach
11 countries

83 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

January 12, 2006

Last Update Submit

July 1, 2020

Conditions

Alzheimer Disease

Keywords

Alzheimer's DiseaseCholinesterase InhibitorsOutpatients

Outcome Measures

Primary Outcomes (1)

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

    6 mo extension study: week 24

Secondary Outcomes (1)

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

    week 24

Study Arms (3)

A

EXPERIMENTAL
Drug: lecozotan SR (SRA-333)

B

EXPERIMENTAL
Drug: lecozotan SR (SRA-333)

C

EXPERIMENTAL
Drug: lecozotan SR (SRA-333)

Interventions

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

ABC

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (83)

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Phoenix, Arizona, 85013, United States

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Tucson, Arizona, 85741, United States

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Costa Mesa, California, 92626, United States

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Fresno, California, 93720, United States

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La Jolla, California, 92037, United States

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Orange, California, 92868, United States

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Delray Beach, Florida, 33445, United States

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Fort Lauderdale, Florida, 33321, United States

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Fort Myers, Florida, 33916, United States

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Hallandale, Florida, 33009, United States

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Hialeah, Florida, 33016, United States

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Jacksonville, Florida, 33216, United States

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Miami, Florida, 33176, United States

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Miami Beach, Florida, 33154, United States

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Orlando, Florida, 32806, United States

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Sarasota, Florida, 34239, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33617, United States

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West Palm Beach, Florida, 33407, United States

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St Louis, Missouri, 63104, United States

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Long Branch, New Jersey, 07740, United States

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Manchester Twp., New Jersey, 08759, United States

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Albany, New York, 12208, United States

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Cedarhurst, New York, 11516, United States

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Staten Island, New York, 10312, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43210, United States

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Tulsa, Oklahoma, 74104, United States

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Philadelphia, Pennsylvania, 19107, United States

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East Providence, Rhode Island, 02914, United States

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Memphis, Tennessee, 38119, United States

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Houston, Texas, 77030, United States

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Bennington, Vermont, 05201, United States

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Av. Belgrano, 2945, Argentina

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Buenos Aires, Argentina

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Calle Adolfo Alsina, 2184, Argentina

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Cervino, 3356, Argentina

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Gascon, 450, Argentina

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Larrea, 1035, Argentina

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Nueva York, 3952, Argentina

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Pilar, 950, Argentina

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Puerto Galván, 4102, Argentina

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Adelaide, 5000, Australia

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East Gosford, 2250, Australia

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Hornsby, 2077, Australia

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Randwick, 2031, Australia

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Victoria, 3081, Australia

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Edmonton, Alberta, T5G 0B7, Canada

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Medicine Hat, Alberta, T1A 4C2, Canada

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Moncton, New Brunswick, E1C 4B7, Canada

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Ottawa, Ontario, K1N 5C8, Canada

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Montreal, Quebec, H4H 1R3, Canada

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Helsinki, 00120, Finland

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Joensuu, 80100, Finland

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Kuopio, 70211, Finland

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Bordeaux, 33076, France

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Montpellier, 34295, France

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Nice, 06002, France

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Toulouse, 31300, France

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Roma, 00143, Italy

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Roma, 00168, Italy

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Gdansk - Wrzeszcz, 00-282, Poland

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Krakow, 30-393, Poland

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Krakow, 31-530, Poland

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Lodz, 92-216, Poland

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Lublin, 20-022, Poland

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Sopot, 81-824, Poland

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Szczecin, 70-356, Poland

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Bloemfontein, 9301, South Africa

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Cape Town, 7500, South Africa

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Johannesburg, 2197, South Africa

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Somerset West, 7130, South Africa

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Barcelona, 08003, Spain

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Barcelona, 08014, Spain

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Barcelona, 08025, Spain

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Barcelona, 08036, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Belfast, BT9 7BL, United Kingdom

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Glasgow, G20 0XA, United Kingdom

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Sheffield, S35 8QS, United Kingdom

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Southampton, SO30 3JB, United Kingdom

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Swindon, SN1 4JU, United Kingdom

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MeSH Terms

Conditions

Alzheimer Disease

Interventions

lecozotan

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 16, 2006

Study Start

March 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

AU(5)AR(9)US(33)ZA(4)GB(5)FI(3)ES(6)PL(7)CA(5)IT(2)FR(4)