Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)
Completed · Phase 2 · Has a placebo group
Conditions studied: Alzheimer's Disease
In brief
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 significantly as the population ages, unless preventative treatments can be identified and marketed. The present study seeks to evaluate AZD3480 (TC-1734) compared to an approved medication (donepezil) shown to improve cognition and function in patients with Alzheimer's disease.
Key facts
- Study ID
- NCT01466088
- Run by
- Targacept Inc.
- People needed
- 386
- Starts
- 2011-10-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2015-06-03
Who can join
Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- Banner Alzheimer Institute — Phoenix, Arizona, United States
- Meridien Research — Brooksville, Florida, United States
- MD Clinical — Hallandale, Florida, United States
- Policlinic — Choceň, Czechia
- BRAIN-SOULTHERAPY s.r.o. — Kladno, Czechia
- Bialbi.s.r.o. Psychiatrické oddělení — Litoměřice, Czechia
- Psychiatricka Ambulance — Olomouc, Czechia
- Vojenska Nemocnice Psychiatricke oddeleni — Olomouc, Czechia
- Clintrial — Prague, Czechia
- PRAGTIS s.r.o. — Prague, Czechia
- Psychosocialni centrum — Přerov, Czechia
- Crucea Alba - Dr. Oros si Asociatii - Societate Civila Medicala — Oradea, Romania
- Spitalul de Psihiatrie Sibiu — Sibiu, Romania
- Spitalul Clinic Judetean de Urgenta SIBIU — Sibiu, Romania
- Spitalul Clinic Judetean de Urgenta, Clinica Psihiatrie — Timișoara, Romania
- Spitalul Clinic Judetean de Urgenta, Clinica Neurologie 2 — Timișoara, Romania
- Neurologicka Ambulancia, s.r.o. — Banská Bystrica, Slovakia
- Univerzitna nemocnica Bratislava, Geronto-psychiatrické oddelenie — Bratislava, Slovakia
- KONZILIUM s.r.o. — Dubnica nad Váhom, Slovakia
- Neurologická ambulancia — Krompachy, Slovakia
- Dnipropetrovsk Regional Clinical Hospital — Dnipropetrovsk, Ukraine
- Donetsk National Medical University of M. Gorky — Donetsk, Ukraine
- Donetsk Regional Clinical Psychiatric Hospital — Donetsk, Ukraine
- Crimean Republican Institution Psychoneurological Dispensary — Kerch, Ukraine
- Central Clinical Hospital Ukrzaliznytsi — Kharkiv, Ukraine
Full record on ClinicalTrials.gov
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