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

NCT00411580 | Completed Phase 1

• 1 other identifier: CCAD106A2101
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

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.

Conditions

Alzheimer's Disease

Keywords

Mild, moderate Alzheimer's Disease (AD), Aß-specific antibody, CAD106

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

CAD106

Biological: CAD106

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CAD106 BIOLOGICAL

1

Placebo DRUG

2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigative Site

Malmo, 204 02, Sweden

Location

Novartis Investigative Site

Stockholm, 141 86, Sweden

Location

Novartis Investigative Site

Stockholm, Sweden

Location

Related Publications (1)

• Winblad B, Andreasen N, Minthon L, Floesser A, Imbert G, Dumortier T, Maguire RP, Blennow K, Lundmark J, Staufenbiel M, Orgogozo JM, Graf A. Safety, tolerability, and antibody response of active Abeta immunotherapy with CAD106 in patients with Alzheimer's disease: randomised, double-blind, placebo-controlled, first-in-human study. Lancet Neurol. 2012 Jul;11(7):597-604. doi: 10.1016/S1474-4422(12)70140-0. Epub 2012 Jun 6.

  PMID: 22677258 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2006
• First Posted: December 14, 2006
• Study Start: June 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

SE (3)