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

Novartis

Status and phase

Completed

Phase 1

Conditions

Alzheimer's Disease

Treatments

Biological: CAD106

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00411580

CCAD106A2101

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.