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Lecozotan

Phase 2

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: May 6, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials6
Total Enrollment559

FDA Designations

No designations recorded

Clinical trial landscape

Lecozotan · 7 trials · 2 indications

Phase 2 2Phase 1 5
NCT00277810Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's DiseaseAlzheimer Disease
COMPLETED250 Analytics
NCT00151398Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)Alzheimer Disease
COMPLETED229 Analytics
PHASE2COMPLETED
Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics
PHASE2COMPLETED
Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
weeks 12, 14, 26 and 40.
Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects
Evaluation of 5-HT toxicity (Hunter serotonin toxicity criteria) and CNS questionnaires.
Pharmacokinetic (PK) analyses
To assess the effect of drug administration on QTc interval.
The incidence of adverse events and adverse reactions will be calculated. The safety variables (vital signs, ECG parameters, and routine laboratory tests) and PK parameters will be measured throughout study period.

Secondary Endpoints

Score change from baseline to 24 weeks on functional and behavioral scales
week 24
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
weeks 12, 14, 26 and 40.
Pharmacokinetic analysis after single and multiple dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
CEXPERIMENTAL -
DACTIVE_COMPARATOR -

Interventions

NameTypeDescription
lecozotan SR (SRA-333)DRUGone 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
lecozotan SRDRUGevaluation 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.
DonepezilDRUG10 mg donepezil QD dosed up to 40 weeks
LecozotanDRUG -
CitalopramDRUG -
MoxifloxacinDRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites83

Inclusion Criteria: * 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 ...

Countries:United StatesArgentinaAustraliaCanadaFinlandFranceItalyPolandSouth AfricaSpainUnited KingdomGermany
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Frequently asked questions about Lecozotan

What is Lecozotan used for?

Lecozotan is an investigational small molecule being studied for use in Alzheimer Disease and in healthy subjects. It is being developed by Pfizer, Inc. (NYSE: PFE) as a potential treatment for neurology-related conditions. The drug is currently in Phase 2 clinical development, though all six completed trials were Phase 1 studies.

Who makes Lecozotan?

Lecozotan is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials of Lecozotan in countries including France, Germany, and the United Kingdom. The drug is an investigational small molecule in the neurology therapeutic area.

What phase is Lecozotan in?

Lecozotan is in Phase 2 clinical development. However, all six clinical trials listed for the drug are completed Phase 1 studies. These trials evaluated the safety, tolerability, and pharmacokinetics of Lecozotan in healthy subjects and in patients with Alzheimer Disease. The drug remains investigational and is not yet approved.

What clinical trials has Lecozotan been in?

Lecozotan has been studied in six completed clinical trials, including NCT00366483, NCT00494962, NCT00499642, and NCT00538889. These Phase 1 trials evaluated safety, tablet formulations, QTc interval effects, and drug interactions with citalopram in healthy subjects. Total enrollment across all trials was 559 participants, with studies conducted in France, Germany, and the United Kingdom.

Is Lecozotan FDA approved?

No, Lecozotan is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Alzheimer Disease. All completed trials for Lecozotan were Phase 1 studies focused on safety and tolerability in healthy subjects. The drug has not yet demonstrated efficacy in late-stage trials and remains under clinical investigation.

What is the development status of Lecozotan for Alzheimer Disease?

Lecozotan is in Phase 2 development for Alzheimer Disease. The completed trials were early-stage Phase 1 studies that enrolled healthy volunteers and subjects with Alzheimer Disease to assess safety and drug interactions. These trials were randomized, double-blind, and controlled. The drug is being developed by Pfizer, Inc. as a potential treatment for the condition.