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Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)
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
Lead sponsor
Assets
AZD3480 / Donepezil
Listed sites
33
Recruiting sites
-
Enrollment
386
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 12-22•Study partner/caregiver required
Primary endpoint
•ADAS-Cog
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. 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.
2. AD diagnosed at least 12 months prior to Screening, and supported by brain imaging studies within 6 months prior to Screening.
3. Absence of vascular dementia both per AIRENS criteria and as defined by modified Hachinski ischemia score (HIS) of </= 4.
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
5. Able to complete test assessments and to sign informed consent with the help of a caregiver if needed
Exclusion criteria
1. Diagnosis or presence of other dementing illnesses
2. Use of mood stabilizers, antidepressants, anxiolytics, antipsychotics or hypnotics
3. Treatment within 1 month prior to Screening using cognition-affecting agents (e.g. CNS stimulants)
4. Tobacco user within 4 months prior to Screening
5. Use of smoking cessation therapy within 4 months prior to Screening
6. History within past 6 months of alcohol abuse or illicit drug abuse
7. Unable, even with caregiver assistance, to comply with study procedures in opinion of investigator
8. Myocardial infarction within the 12 months prior to Screening
9. Hypothyroidism, vitamin B12 or folic acid deficiency
10. Known systemic infection (HBV, HCV, HIV, TB)
11. 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).
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
4 endpointsChange from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Time frame:52 weeks
ADAS-Cog
change from baseline, improvement
Change from baseline in the Clinician Interview-Based Impression of Change plus carer interview [CIBIC-(+)]
Time frame:52 Weeks
ADAS-Cog
change from baseline, improvement
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame:52 Weeks
ADAS-Cog
change from baseline, improvement
Change from baseline in the Mini-Mental State Examination (MMSE)
Time frame:52 Weeks
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Behavior / neuropsychiatric
1 endpointChange from baseline in the Neuropsychiatric Inventory (NPI)
Time frame:52 Weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Caregiver / quality of life
1 endpointChange from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL)
Time frame:52 Weeks
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.