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Completed

NCT Number: NCT00795418

Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ATP Clinical Research, Costa Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and/or female patients between 40 and 85 years of age (both inclusive)
  • Diagnosis of mild Alzheimer's Disease (AD)
  • Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks.

Exclusion criteria

  • Previously participated in an AD vaccine study and received active treatment.
  • History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
  • History or presence of seizures and/or cerebrovascular disease.
  • Presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
  • Advanced, severe, progressive or unstable disease that might interfere with the safety of the patient.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Placebo

Biological

Placebo comparator

CAD106

Biological

Primary outcomes

  1. Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)

    Time frame: 52 weeks

Secondary outcomes

  1. Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.

    Time frame: 52 weeks

  2. Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.

    Time frame: 52 weeks

  3. Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106

Important dates

Study start
2008
Primary completion
2010
First posted
Nov 21, 2008
Registry last updated
Dec 17, 2020

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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