AZD3480 for Mild to Moderate Dementia of the Alzheimer's Type
AZD3480 for Mild to Moderate Dementia of the Alzheimer's Type
Overall Status:
Recruiting
Brief Description:
This study will test the efficacy, safety, and tolerability of the experimental drug AZD3480 in people with mild to moderate Alzheimer's disease. It will also compare the drug to donepezil as a potential disease-modifying treatment.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
60 Years | 85 Years | Both | Accepts Healthy Volunteers |
Inclusion Criteria:
- Clinical diagnosis of Alzheimer's disease, mild to moderate severity, defined by Mini-Mental State Examination (MMSE) score of 12 to 22
- Alzheimer's disease diagnosed at least 12 months prior to screening and supported by brain imaging studies within 6 months prior to screening
- Caregiver with significant contact with subject who can oversee administration of study drug
Exclusion Criteria:
- Diagnosis or presence of other dementing illnesses
- Use of mood stabilizers, antidepressants, anxiolytics, antipsychotics or hypnotics
- Treatment with cognition-affecting agents (e.g., central nervous system stimulants) within 1 month prior to screening
- Use of tobacco or smoking cessation therapy within 4 months prior to screening
- History of alcohol abuse or illicit drug abuse within past 6 months
- Heart attack within 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 > 4
Detailed Description:
AZD3480 is a novel small molecule that acts selectively on the alpha4beta2 neuronal nicotinic receptor. The effects on cognition will be compared to those of donepezil, which is widely used in the long-term treatment of Alzheimer's disease, during 1 year. The dose of AZD3480 evaluated in this study, a 30-mg capsule, reflects an appropriate dose based on earlier findings. Participants with mild to moderate Alzheimer's have been specifically selected to enhance the likelihood of seeing a difference in effectiveness of AZD3480 compared to donepezil.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 33.4636012, -112.0535987 | Phoenix | Arizona | 85006 | Name: Phone: | ||
Geolocation is 28.5552719, -82.3878709 | Brooksville | Florida | 34601 | Name: Phone: | ||
Geolocation is 25.9812024, -80.148379 | Hallandale Beach | Florida | 33009 | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
Targacept Inc. |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Pierre Tariot, MD | Principal Investigator | Banner Alzheimer's Institute |
Study Contact:
| Name | Phone | |
|---|---|---|
Gaston Farr, MA | 336-480-2289 |
Locations
ClinicalTrials.gov ID
NCT01466088 (follow link to view full record on ct.gov in new window)
Official Title:
Double-Blind, Positive Comparator, Randomized, Parallel Study of Efficacy, Safety, and Tolerability of AZD3480 (TC-1734-226) as Monotherapy in Patients with Mild to Moderate Dementia of the Alzheimer's Type
Study Start Date:
October 2011
Study End Date:
November 2013
Disease Stage:
Early
Middle
Enrollment:
300
