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CompletedPhase 2

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

Targacept Inc.

Assets

AZD3480 / Donepezil

Listed sites

33

Recruiting sites

-

Enrollment

386

actual

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMMSE 12-22Study 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

NCT IDNCT01466088
Org study IDTC-1734-226-CRD-006

Timeline

Milestones

Study start2011-10 (month precision)
Study first posted2011-11-07estimated
Primary completion2014-05actual (month precision)
Study completion2014-05actual (month precision)
Last update posted2015-06-03estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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
Behavior / neuropsychiatric
1
Caregiver / quality of life
1

Global cognition

4 endpoints
Primary/protocol endpoint

Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)

Time frame:52 weeks

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

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

Primary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Change from baseline in the Neuropsychiatric Inventory (NPI)

Time frame:52 Weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Change from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL)

Time frame:52 Weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.