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

Alzheimer's Disease Clinical Trial

Official title:

A 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Time-lagged, Parallel Group Study in Patients With Mild to Moderate Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Aß-specific Antibody Response Following Three Subcutaneous Injections of CAD106

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411580
• Other study ID #: CCAD106A2101
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2006
• Last updated: March 27, 2013
• Start date: June 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• CAD106

Drug:
• Placebo

Locations

Country	Name	City	State
Sweden	Novartis Investigative Site	Malmo
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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	No
Secondary	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	No