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

• ClinicalTrials.gov Identifier: NCT00795418
• Recruitment Status: Completed
• First Posted: November 21, 2008
• Last Update Posted: December 17, 2020
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Tracking Information

• First Submitted Date: November 10, 2008
• First Posted Date: November 21, 2008
• Last Update Posted Date: December 17, 2020
• Study Start Date: October 2008
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 20, 2008): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 20, 2008)

• Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ]
• Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ]
• Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
• Official 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
• Brief Summary: This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alzheimer's Disease

Intervention

• Biological: Placebo
  Placebo comparator
• Biological: CAD106

Study Arms

• Experimental: CAD106
  Intervention: Biological: CAD106
• Placebo Comparator: Placebo
  Intervention: Biological: Placebo

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2010): 31
• Original Estimated Enrollment (submitted: November 20, 2008): 30
• Study Completion Date: Not Provided
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00795418
• Other Study ID Numbers: CCAD106A2202
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis
• Original Responsible Party: External Affairs, Novartis Pharmaceuticals
• Current Study Sponsor: Novartis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: May 2012