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CompletedNCT00795418Updated Dec 17, 2020

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

A Phase 2 interventional study of Placebo and CAD106 in Alzheimer's Disease, sponsored by Novartis. Completed at 10 sites in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Novartis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • Active immunization
  • Alzheimer's disease
  • Antibody
  • Vaccine
  • Central Nervous System Diseases
  • Neurodegenerative diseases
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 31 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    CAD106

    Biological: CAD106

  • Placebo comparator
    Placebo

    Biological: Placebo

Interventions

  • BiologicalPlacebo

    Placebo comparator

  • BiologicalCAD106
06

What researchers measure

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

07

Study locations

10 sites
  • ATP Clinical Research
    Costa Mesa, California 92626, United States
  • Alpine Clinical Research Center
    Boulder, Colorado 80304, United States
  • Sunrise Clinical Research
    Hollywood, Florida 33021, United States
  • Alexian Brothers Neuroscience Institute
    Elk Grove Village, Illinois 60007, United States
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
  • MidAmerica NeuroScience Research Foundation
    Lenexa, Kansas 66214, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Drexel University College of Medicine
    Philadelphia, Pennsylvania 19102, United States
  • NOCCR Knoxville
    Knoxville, Tennessee 37920, United States
  • University of Texas Southwestern
    Dallas, Texas 75390-9139, United States
08

References and documents

Publications

  • Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015. PubMed 25918556 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00795418
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Nov 21, 2008
Start date
Oct 2008
Primary completion
Nov 2010
Last update
Dec 17, 2020

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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