EUCTR2011-000487-10-CZActive, not recruitingNot Applicable
A Double-Blind, Positive Comparator, Randomized, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of AZD3480 (TC-1734-226) as Monotherapy in Patients with Mild to Moderate Dementia of the Alzheimer’s Type (AD). - Not applicable
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Targacept, Inc.
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. A clinical diagnosis of probable dementia of the Alzheimer’s type (Alzheimer’s disease; AD) per National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria at least 12 months prior to Screening, supported by brain imaging studies within the previous 6 months, and of mild to moderate severity as defined by a Mini-Mental State Examination (MMSE) score of 12 to 22.
- •2. Age 60-85, males or females.
- •3. Presence of a caregiver with significant proportion of time in contact with the subject and who will oversee administration of study drug during the trial.
- •4. Able to complete tests assessments and to understand and sign an informed consent (with help of his/her legally authorized representative if needed).
- •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. Vascular dementia, verified per National Institute of Neurological Disorders and Stroke and Association Internationale pour la Rechererchi et l’Enseignement en Neurosciences (NINDS-AIRENS) criteria and as defined by a modified Hachinski ischemia score (HIS) score of > 4 (i.e., vascular dementia is consistent with a modified HIS > 4).
- •2. Diagnosis or presence of other dementing illnesses.
- •3. Use of specified prohibited medications (Refer to protocol section 5.3.2 Prohibited Medications).
- •4. Treatment within 1 month prior to Screening using cognition-affecting agents (e.g., CNS stimulants).
- •5. Tobacco user within 4 weeks prior to Screening.
- •6. Use of smoking cessation therapy within 4 weeks prior to Screening.
- •7. History within past 6 months of alcohol abuse or illicit drug abuse.
- •8. Unable, even with caregiver assistance, to comply with study procedures in opinion of investigator.
- •9. History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder: or diagnosis of major depressive disorder.
- •10. Myocardial infarction within 12 months prior to Screening.
- •11. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency.
- •12. Known systemic infection (HBV, HCV, HIV, TB).
- •13. Clinically significant finding on baseline physical examination.
- •14. Clinically significant baseline laboratory or ECG abnormality, including QTcF > 450 msec (for males) and > 470 for females.
- •15. The subject is pregnant.
- •16. Males or WOCBP (FSH >35 IU/L and a LH level >25 IU/L) who are unwilling to comply with contraceptive measures as described in the protocol.
- •17. Malignancies within 3 years of screening. Malignancies successfully treated greater than three years prior to screening are permitted. Current skin malignancies other than Malignant Melanoma are allowed.
- •18. Participation in another clinical trial in the past 3 months, where subjects were required to take study drug.
Investigators
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