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 - N/A

• Register: EUCTR
• Last refreshed on: 7 September 2021
• Main ID: EUCTR2005-001475-35-ES
• Date of registration: 27/06/2005
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
• Public 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 - N/A
• Scientific 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 - N/A
• Date of first enrolment: 23/03/2006
• Target sample size: 355
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001475-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Finland, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
2. Men and postmenopausal or surgically sterile women aged 50 years or older. Postmenopausal women must have had at least 12 months of spontaneous amenorrhea. Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), or bilateral tubal ligation.
3. Mini-Mental State Examination (MMSE) score of 12 to 26.
4. Rosen Modified Hachinski Ischemic score =< 4.
5. Lives at home with appropriate caregiver, or community dwelling with caregiver capable of accompanying patient on all clinic visits and visiting the patient at least daily for the duration of the study.
6. Computed tomography (CT) or magnetic resonance imaging (MRI) scan within the past 2 years (performed after onset of dementia) consistent with the diagnosis of AD. There should be no clinical evidence of stroke since completion of the imaging study (one lacuna, in areas not related to cognitive function, eg, cerebellum or deep white matter, will not exclude the patient).
7. Able to give signed and dated written informed consent in accordance with local regulations. The patient’s caregiver will also consent to participate in the study.
8. Able to complete all required neuropsychological tests.
9. Fluency in local language.
10. Receiving stable doses of medications for the treatment of nonexcluded medical conditions for 30 days before screening.
11. Able to participate in all scheduled evaluations and complete all required tests.
12. In the opinion of the investigator, the patient and caregiver will be compliant and have a high probability of completing the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Significant neurological disease other than AD that may affect cognition (eg, epilepsy, Parkinson disease) or ability to complete the study.
2. Current diagnosis of a major depressive disorder or other major psychiatric symptoms included in psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM IV-TR), criteria.
3. Current clinically significant systemic illness that, in the judgment of the investigator, is likely to deteriorate or affect the patient’s safety, influence cognitive assessment, or ability to complete the study.
4. History of seizure, except febrile childhood febrile seizures.
5. History of clinically evident stroke or clinically significant carotid or vertebrobasilar stenosis or plaque.
6. Myocardial infarction within the last 3 months.
7. History of cancer within the last 5 years, with the exception of nonmetastatic basal and/or squamous cell carcinoma of the skin
8. Excessive smoking (greater than 20 cigarettes a day).
9. History of alcohol or drug dependence within the last 1 year.
10. Hamilton Psychiatric Rating Scale for Depression, 21 items (HAM-D21) score > 17.
11. Any clinically significant abnormality in physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that in the judgment of the investigator, is likely to deteriorate or affect the patient’s safety or ability to complete the study.
12. History of any clinically important multiple drug allergies, that will compromise the patient’s safety during the study.
13. Use of prescription or nonprescription medications for medications for cognitive enhancement, (including memantine, and the use of cholinesterase inhibitors) within 3 months of the baseline visit. History of clinically significant side effects attributable to cholinesterase inhibitors and any history of intolerance, or lack of response to cholinesterase inhibitors.
14. Any use of experimental drugs investigational drugs or procedures, including experimental medications for AD, within 30 days of baseline visit.
15. Current use of anticonvulsant, anti Parkinson, antipsychotic, antidepressant medication and buspirone within 30 days of baseline visit (except for fluoxetine, which is excluded within 60 days of baseline).
16. Regular use of narcotic medications within 30 days of baseline visit.
17. Treatment with strong inhibitors of the cytochrome P450 3A4 isoenzyme system (i.e. ketoconazole, itraconazole, erythromycin, clarithromycin) within 1 week of baseline visit.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Intervention(s)

Product Name: Lecozotan SR
Product Code: SRA-333 SR
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Lecozotan
CAS Number: 433282-68-9
Current Sponsor code: SRA-333
Other descriptive name: WAY-161333 HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use

Product Name: Lecozotan SR
Product Code: SRA-333 SR
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Lecozotan
CAS Number: 433282-68-9
Current Sponsor code: SRA-333
Other descriptive name: WAY-161333 HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use

Trade Name: Aricept
Product Name: Aricept (encapsulated and powder filled)
Pharmaceutical Form: Tablet
INN or Proposed INN: Donepezil Hydrochloride
CAS Number: 120011-70-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The primary objective is to determine the safety, tolerability, and efficacy of 3 doses of Lecozotan (SRA-333) SR (2 mg, 5 mg and 10 mg) in patients with mild to moderate AD over 12 weeks.

Primary end point(s): The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC at week 12.

Secondary Objective: Secondary objectives are to estimate comparative safety, tolerability and efficacy versus donepezil over a 12-week period in patients with AD and to measure the responsiveness of patient and caregiver-reported outcomes instruments.

Secondary ID(s)

3098B1-201

Ethics review

Status: Approved
Approval date: 13/03/2006
Contact:

Results

• Results available: Yes
• Date Posted: 16/07/2016
• Date Completed: 01/06/2007
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-001475-35/results