Status:
COMPLETED
Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)
Lead Sponsor:
Targacept Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
Brief Summary
Alzheimer's disease is the most common form of dementia and is the fourth leading cause of death among people 65 years of age and older. The global prevalence of the disease will increase significantl...
Detailed Description
This is a double blind, positive comparator, randomized, multicenter, parallel group study to assess the efficacy, safety, and tolerability of AZD3480 as monotherapy in patients with mild to moderate ...
Eligibility Criteria
Inclusion
- A clinical diagnosis of AD per NINCDS-ADRDA criteria; mild to moderate severity as defined by Mini-Mental State Examination (MMSE) scores of 12 to 22.
- AD diagnosed at least 12 months prior to Screening, and supported by brain imaging studies within 6 months prior to Screening.
- Absence of vascular dementia both per AIRENS criteria and as defined by modified Hachinski ischemia score (HIS) of \</= 4.
- Presence of a caregiver with significant proportion of time in contact with subject and who will oversee administration of study drug during the trial
- Able to complete test assessments and to sign informed consent with the help of a caregiver if needed
Exclusion
- Diagnosis or presence of other dementing illnesses
- Use of mood stabilizers, antidepressants, anxiolytics, antipsychotics or hypnotics
- Treatment within 1 month prior to Screening using cognition-affecting agents (e.g. CNS stimulants)
- Tobacco user within 4 months prior to Screening
- Use of smoking cessation therapy within 4 months prior to Screening
- History within past 6 months of alcohol abuse or illicit drug abuse
- Unable, even with caregiver assistance, to comply with study procedures in opinion of investigator
- Myocardial infarction within the 12 months prior to Screening
- Hypothyroidism, vitamin B12 or folic acid deficiency
- Known systemic infection (HBV, HCV, HIV, TB)
- Vascular dementia per NINDS-AIRENS criteria and as defined by a modified Hachinski ischemia score (HIS, Appendix 4) score of \> 4 (i.e., vascular dementia is consistent with a modified HIS \> 4).
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT01466088
Start Date
October 1 2011
End Date
May 1 2014
Last Update
June 3 2015
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Alzheimer Institute
Phoenix, Arizona, United States, 85006
2
Meridien Research
Brooksville, Florida, United States, 34601
3
MD Clinical
Hallandale, Florida, United States, 33009
4
Policlinic
Choceň, Czechia