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Completed

NCT Number: NCT01795339

A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's Patients

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

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Key information

Conditions

Healthy Elderly Volunteers Mild-to-moderate Alzheimer's Disease Patients

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Glendale, California, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD3293

Drug

Oral solution

Placebo

Drug

Oral solution

Primary outcomes

  1. Adverse event monitoring

    Time frame: From Baseline up to 20 days

  2. Assessment of vital signs (blood pressure, pulse and body temperature) and physical exams

    Time frame: From Baseline up to 20 days

  3. Clinical laboratory tests (chemistry, hematology, urinalysis, renal safety)

    Time frame: From Baseline up to 20 days

  4. Assessment of 12-lead digital electrocardiograms to measure rhythm, rate, morphology, QT/QTc interval

    Time frame: Fron Baseline up to 20 days

  5. Assessment of telemetry, as reported by Investigator Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: From Baseline up to 20 days

    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 outcomes

  1. Investigation of the effect of AZD3293 on plasma and cerebrospinal fluid (CSF) biomarkers relevant for Alzheimer Disease (AD)

    Time frame: Up to 17 days

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2013
Registry last updated
Apr 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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