A Randomized, Controlled, Parallel Group, Patient-blinded, Single-center, Phase I Pilot Study to Assess the Tolerability and Safety of Repeated Administrations of a Single-dose of AFFITOPE AD03 to Alzheimer's Disease Patients

Affiris AG1 site in 1 country28 target enrollmentOctober 2010

ConditionsAlzheimer's Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Affiris AG
Enrollment: 28
Locations: 1
Primary Endpoint: change in ADAS-Cog score as a measure of cognition
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, controlled, parallel group, patient-blinded, single-center, phase I pilot study to assess tolerability and safety of repeated subcutaneous administration of a single-dose of AFFITOPE AD03 applied with or without adjuvant to patients with mild to moderate Alzheimer's disease.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

November 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Affiris AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of probable Alzheimer's disease based on the NINCDS/ADRDA criteria.
•Assessing the severity of AD by the Mini Mental State Examination (MMSE). AD of mild degree has been confirmed if the MMSE score is in the range of 20 to
•Hachinski Ischemia Scale is used to try and distinguish AD from multi-infarct dementia. A score of ≤ 4 suggests AD.
•The result of the Magnetic Resonance Imaging scan (MRI) of the patient's brain has to be consistent with the diagnosis of AD
•Written informed consent signed and dated by the patient and the caregiver. The patient's capability to give informed consent has to be confirmed by an independent psychiatrist or neurologist.
•Age between 50 and 80 years.
•Availability of a partner/caregiver knowing the patient and being able to accompany the patient at the visits and being available for the telephone interviews. This is necessary because some of the neuropsychiatric tests require information by a person knowing the patient well. In addition, it increases the safety of a study participant.
•Adequate visual and auditory acuity to allow neuropsychological testing.
•Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
•Availability of the APOE status

Exclusion Criteria

•Pregnant women.
•Sexually active women of childbearing potential who are not using a medically accepted birth control method.
•Participation in another clinical trial within 3 months before Visit
•History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
•Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
•Contraindication for MRI imaging such as metallic endoprosthesis or stent implantation in the last 6 months or allergy to MRI contrast agent.
•Operation (under general anaesthesia) within 3 months prior to study entry and scheduled elective operation during the whole study period.
•History and/or presence of autoimmune disease, if considered relevant by the investigator.
•Recent (≤3 years since last specific treatment) history of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia).
•Active infectious disease (e.g., Hepatitis B, C).