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

NCT ID: NCT00795418

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CAD106

Group Type EXPERIMENTAL

CAD106

Intervention Type BIOLOGICAL

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo comparator

Interventions

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Placebo

Placebo comparator

Intervention Type BIOLOGICAL

CAD106

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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ATP Clinical Research

Costa Mesa, California, United States

Site Status

Alpine Clinical Research Center

Boulder, Colorado, United States

Site Status

Sunrise Clinical Research

Hollywood, Florida, United States

Site Status

Alexian Brothers Neuroscience Institute

Elk Grove Village, Illinois, United States

Site Status

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

MidAmerica NeuroScience Research Foundation

Lenexa, Kansas, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

NOCCR Knoxville

Knoxville, Tennessee, United States

Site Status

University of Texas Southwestern

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25918556 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4704

Results for CCAD106A2202 from the Novartis Clinical Trials website

Other Identifiers

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CCAD106A2202

Identifier Type: -

Identifier Source: org_study_id

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