A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00736775
• Date of registration: 15/08/2008
• Primary sponsor: Genentech
• Public title: A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease
• Scientific title: A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous MABT5102A Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Mild to Moderate Alzheimer's Disease
• Date of first enrolment: August 2008
• Target sample size: 56
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00736775
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Carole Ho, M.D.
• Affiliation: Genentech

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of probable AD according to the NINCDS-ADRDA Criteria

- Approved AD treatments (AchE inhibitors+/-memantine) must be stable for = 3 months
prior to screening

- Other prescription medications must be stable for = 1 month prior to screening

Exclusion Criteria:

- Female patients with reproductive potential

- History or presence of any clinically significant CNS disease

- History of treatment with any protein therapeutic targeting Abeta



Age minimum: 50 Years
Age maximum: 86 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Intervention(s)

Drug: anti-Abeta

Drug: placebo

Primary Outcome(s)

Safety and tolerability of single and multiple doses of MABT5102A [Time Frame: Through study completion or early study discontinuation]

Secondary Outcome(s)

Immunogenicity of MABT5102A after single and multiple doses [Time Frame: Through study completion or early study discontinuation]

Pharmacokinetics of MABT5102A after single and multiple doses [Time Frame: Through study completion or early study discontinuation]

Secondary ID(s)

ABE4427g

Source(s) of Monetary Support

Please refer to primary and secondary sponsors