Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AD03 Applied During AFF005A

Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD03 Applied During AFFiRiS 005A

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01568086

Enrollment

Registered

2012-04-02

Start date

2011-12-31

Completion date

2013-10-31

Last updated

2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Written informed consent signed and dated by the patient and the caregiver. * Patients having participated in AFFiRiS 005A and received ≥1 vaccination with AFFITOPE AD03 * Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls

Exclusion criteria

* Patients having received no vaccination with AFFITOPE AD03 * History of questionable compliance to visit schedule; patients not expected to complete the clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Safety/Tolerability	52 weeks	* Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal * Number and kind (description) of AEs * Number and kind (description) of SAEs * Changes from study AFF005A in: Physical and neurological examination/ Concomitant medication/ Vital signs (blood pressure, heart rate, respiratory rate, body temperature)/ Body mass (weight)/ MRI of the brain/ ECG/ Laboratory assessment (haematology, biochemistry, coagulation, serology, APP crossreactivity and urinalysis)

Secondary

Measure	Time frame	Description
Clinical Efficacy	52 weeks	Changes from study AFF005A in: * CIBIC plus (Clinician's Interview-Based Impression of Change, + carer interview) * ADAScog (Alzheimer Disease Assessment Scale-cognitive) * CERAD plus (The Consortium to Establish a Registry for AD) * Neuropsychiatric inventory * Activity of daily living * Quality of life in patients with Alzheimer's disease * Investigator's global evaluation scale * MRI brain volumetry
Immunological	52 weeks	\- Titre of antibodies specific for the immunizing peptide, N-terminal part of Aβ, Aβ itself, N-terminally truncated and Pyroglutamate-modified versions of Aβ, and KLH by ELlSA

Countries

Austria

Outcome results