Trial record 15 of 301 for:
alzheimer | Open Studies | Interventional Studies
A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's Patients
This study is currently recruiting participants.
Verified March 2013 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01795339
First received: February 18, 2013
Last updated: March 22, 2013
Last verified: March 2013
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Purpose
This is a two-part multiple dose study in healthy male and female (of non-child bearing potential) elderly volunteers, and in Alzheimer's disease patients, to assess the safety, effects on the body, and blood, CSF, and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Elderly Volunteers Mild-to-moderate Alzheimer's Disease Patients |
Drug: AZD3293 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | A Phase I, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Plasma and Cerebrospinal Fluid in Healthy Male and Non-Fertile Female Elderly Volunteers and in Mild-to-Moderate Alzheimer Disease Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Adverse event monitoring [ Time Frame: From Baseline up to 20 days ] [ Designated as safety issue: Yes ]
- Assessment of vital signs (blood pressure, pulse and body temperature) and physical exams [ Time Frame: From Baseline up to 20 days ] [ Designated as safety issue: Yes ]
- Clinical laboratory tests (chemistry, hematoloty, urinalysis, renal safety) [ Time Frame: From Baseline up to 20 days ] [ Designated as safety issue: Yes ]
- Assessment of 12-lead digital electrocardiograms to measure rhythm, rate, morphology, QT/QTc interval [ Time Frame: Fron Baseline up to 20 days ] [ Designated as safety issue: Yes ]
- Assessment of telemetry, as reported by Investigator Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: From Baseline up to 20 days ] [ Designated as safety issue: Yes ]Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Secondary Outcome Measures:
- Investigation of the effect of AZD3293 on plasma and cerebrospinal fluid (CSF) biomarkers relevant for Alzheimer Disease (AD) [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
- Investigation of the effect of AZD3293 on plasma and cerebrospinal fluid (CSF) biomarkers relevant for Alzheimer Disease (AD) in mild-moderate AD patients in comparison to elderly healthy volunteers [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
- Investigation of the multiple dose Pharmacokinetics for AZD3293 and its metabolite AZ13569724, including dose proportionality for AZD3293 following oral administration [ Time Frame: Up 17 days ] [ Designated as safety issue: No ]
- Investigation of the Pharmacokinetics/Pharmacodynamics relationship of the effect of AZD3293 on biomarkers relevant for Alzheimer Disease (AD) in plasma [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AZD3293
Part 1: Up to 5 sequential cohorts of healthy elderly subjects are planned, with multiple ascending doses, starting with 5 mg (subject to confirmation by the Safety Review Committee) Part 2: Up to 16 mild-to-moderate AD patients administered one to up to 3 dosage levels of AZD3293
|
Drug: AZD3293
Oral solution
|
|
Placebo Comparator: Placebo
Part 1: Placebo given (2 subjects in each cohort) Part 2: Placebo given (up to 4 subjects)
|
Drug: Placebo
Oral solution
|
Detailed Description:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Plasma and Cerebrospinal Fluid in Healthy Male and Non-Fertile Female Elderly Volunteers and in Mild-to-Moderate Alzheimer Disease Patients
Eligibility| Ages Eligible for Study: | 55 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Part 1: Healthy elderly male and female (of non-childbearing potential) subjects.
- Part 2: Male and non-fertile female AD patients.
- Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
- Part 2: Clinical diagnosis of probable AD according to the NINCDS-ADRDA criteria.
- Part 2: Manifestation of AD symptoms at least 6 months before randomization.
Exclusion Criteria:
- Part 1: History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders.
- Part 2: Significant disease affecting the CNS other than Alzheimer's disease, including but not limited to other dementias, other significant neurological or major psychiatric disease.
- History of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
- Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
- History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01795339
Contacts
| Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
| Contact: Dorothy Chambers | 818 254 1828 | Dorothy.chambers@parexel.com |
Locations
| United States, California | |
| Research Site | Recruiting |
| Glendale, California, United States | |
| Contact: David Han | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Robert C Alexander, MD | AstraZeneca |
| Principal Investigator: | David Han, MD | PAREXEL/CCT Early Phase Clinical Unit |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01795339 History of Changes |
| Other Study ID Numbers: | D5010C00002 |
| Study First Received: | February 18, 2013 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by AstraZeneca:
|
AZD3293 Healthy volunteers Elderly volunteers Alzheimer's Disease patients |
AD patients Phase 1 Multiple Ascending Dose Study |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013