Tolerability and Safety of Subcutaneous Administration of Affitope AD01 in Mild to Moderate Alzheimer's Disease

NCT00495417 | Completed Phase 1 DMC

• 2 other identifiers: Affiris 001EUDRACT Number 2006-007063-90
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the tolerability and safety of repeated subcutaneous injection of a single dose of Affitope AD01 in patients with mild to moderate Alzheimer's Disease.

Conditions

Alzheimer's Disease

Keywords

Alzheimer; Morbus Alzheimer; Alzheimer Vaccine; Vaccine; AD; Aβ immunotherapy

Outcome Measures

Primary Outcomes (1)

• Tolerability

  One year

Secondary Outcomes (1)

• Immunological and clinical efficacy (evaluated in explorative manner)

  One year

Study Arms (2)

1

ACTIVE COMPARATOR

Biological: AFFITOPE AD01

2

ACTIVE COMPARATOR

Biological: AFFITOPE AD01 adjuvanted

Interventions

AFFITOPE AD01 BIOLOGICAL

s.c. injection

1

AFFITOPE AD01 adjuvanted BIOLOGICAL

s.c. injection

2

Eligibility Criteria

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

You may qualify if:

• Diagnosis of probable Alzheimer's disease based on the NINCDS/ADRDA criteria.
• Assessing the severity of Alzheimer's disease of mild to moderate degree by the Mini Mental State Examination (MMSE 16-26)
• Hachinski Ischemia Scale ≤ 4.
• Magnetic Resonance Imaging scan (MRI) of brain consistent with diagnosis of AD.
• Informed consent capability (as determined by an independent neurologist)
• Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver.
• Age \>50 years.
• Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone interviews.
• Adequate visual and auditory acuity to allow neuropsychological testing.
• Female patients of childbearing potential using a medically accepted contraceptive method.
• AD therapies on stable doses for at least 3 months prior to Visit 1 and during the entire trial period.
• Stable doses of all other medications for at least 30 days prior to Visit 1 if considered relevant by the investigator.

You may not qualify if:

• Pregnant women.
• Sexually active women of childbearing potential not using a medically accepted birth control method.
• Presence or history of allergy to components of the vaccine.
• Contraindication for MRI imaging.
• Operation (under general anaesthesia) within 3 months prior to study entry and scheduled elective operation during the whole study period.
• Participation in another clinical trial.
• History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
• Prior and/or current treatment with experimental immunotherapeutics including IVIG or vaccines for AD.
• Prior and/or current treatment with immunosuppressive drugs, concurrent treatment with beta-blockers.
• History and/or presence of autoimmune disease.
• Recent (≤3 years since last specific treatment) history of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia).
• Major psychiatric disorder (e.g. schizophrenia), if considered relevant by the investigator.
• Active infectious disease (e.g., Hepatitis B, C).
• Presence and/or history of Immunodeficiency (e.g., HIV).
• Significant neurological disease other than AD.

Sponsors & Collaborators

• Affiris AG: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Markus Müller, UnivProf.Dr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 3, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 19, 2010

Record last verified: 2009-09

Locations

AU (1)