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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2005-000048-10-SE
Date of registration:	21/02/2005
Prospective Registration:	Yes
Primary sponsor:	Novartis Pharma Services AG
Public title:	A 52-week, multi-center, randomized, double-blind, placebo-controlled, time-lagged, parallel group study in patients with mild to moderate Alzheimer's Disease (AD) to investigate the safety, tolerability and Abeta-specific antibody response following three subcutaneous injections of CAD106
Scientific title:	A 52-week, multi-center, randomized, double-blind, placebo-controlled, time-lagged, parallel group study in patients with mild to moderate Alzheimer's Disease (AD) to investigate the safety, tolerability and Abeta-specific antibody response following three subcutaneous injections of CAD106
Date of first enrolment:	20/04/2005
Target sample size:	60
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000048-10
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: yes Other:
Phase:

Countries of recruitment
Sweden

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Males and females (non-child bearing0 aged 50 to 80 years old
Mini Mental State Exam score between 16 and 26
Outpatients with caregiver
Diagnostic and Statistical manual of Mental Disorders (4th edition) criteria for dentia of the Alzheimer's type
Clinical diagnosis of probable Alzheimer's disease according to Natinal Institure of Neurological and Communicative Disordrs and Stroke-Alzheimer's Disease and Related Disorders Association
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Previous participation in Alzheimer's disease vaccine trial and received active treatment
History or presence of aoutoimmune and/or cerebrovascular disease
Immunosuppressive therapy, including steroids
Vaccinated within 4 weeks before the first study drug injection

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Alzheimer's disease

Intervention(s)

Product Code: CAD106
Pharmaceutical Form: Solution for injection
Current Sponsor code: CAD106
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: To evaluate safety and tolerabiltiy of repeated subcutaneous injections of CAD106 in patients with mild to moderate Alzheimer's disease.

To determine time-course and decline, and isotype switch from IgM to Ig Gof the Abeta-specific antibody response in serum, using the Enzyme inked Immunosorbent Assay (ELISA), following rpeated subcutaneous injections of CAD106 or placebo

Primary end point(s): Adverse event reports
Isotype switch from IgM to IgG of the Abeta-specific antibodies in serum

Secondary Objective: Explore characteristics of Abeta-antibodies in serum and CSF
Characterize Abeta-specific T0cell lympohocytes
Explore effects on disease progression
Explore effects on concentrations of disease related markers
Perform exploratory phamacogenetic assessments
Conduct exploratory genomic, proteomic and metabonomic assessments

Secondary Outcome(s)

Secondary ID(s)

CCAD106A2101

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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