Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: CAD106; Drug: Placebo

• Registration Number: NCT00411580
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the safety and tolerability and Aß-specific antibody response of CAD106 in patients with mild to moderate Alzheimer's Disease.

Patients also had a 2 year follow-up to assess disease progression where no drug was administered.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-12-13
• Study First Submitted QC: 2006-12-13
• Study First Posted: 2006-12-14
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• males and/or females patients between 50 to 80 years of age (both inclusive).
• female patients must be without childbearing potential (post-menopausal or surgically sterilized).
• diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders, 4th edition).
• mild to moderate AD as confirmed by Mini-Mental State Exam score of 16 to 26 (both inclusive) at screening.
• able to provide written informed consent and having a responsible caregiver that can provide written assent prior to study participation. For patients who have been declared mentally incompetent, a legal representative will need to provide informed consent on their behalf.

Exclusion Criteria

• previously participated in an AD vaccine study and received active treatment
• history or presence of an active autoimmune and/or cerebrovascular disease
• history or presence of seizures, with an acute or chronic inflammation
• clinically relevant atopic condition, who suffer from an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
• immunosuppressive treatment including systemic steroids
• obtained a vaccination (e.g. against influenza) within 4 weeks before the first study drug injection
• advanced, severe, progressive or unstable disease that might interfere with the safety of the patient
• started treatment with psychotropic medication within 3 months (4 weeks for SSRIs and other newer antidepressants without anticholinergic properties) prior to randomization with the exception of mild hypnotic drugs (e.g. zolpidem, zopiclone, oxazepam) and low doses of neuroleptic drugs (e.g. up to 2 mg risperidone).

Patients, who are on stable treatment with cholinesterase-inhibitors (ChEIs) and/or memantine for at least 3 months, and/or with SSRIs and/or other newer antidepressants (without anticholinergic properties) for at least 4 weeks before randomization, can be included into the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CAD106	CAD106
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Tolerability/safety assessments (physical/neurol.exam., ECG, vital signs, standard and special immunological laboratory evaluations, MRIs, EEGs, AE/SAE monitoring).	at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
Antibody titers (IgM and IgM titers against amyloid and carrier protein).	at multiple timepoints including but not limited to baseline and through the end of the study to Week 52

Secondary Outcome Measures

Name	Time	Method
Immune response, cognitive and functional assessments	at multiple timepoints including but not limited to baseline and through the end of the study to Week 52

Trial Locations

Locations (1)

Novartis Investigative Site; 🇸🇪 Stockholm, Sweden