Back to resultsA Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
anti-Abeta
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring AD, Alzheimer's, Alzheimers
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Safety and tolerability of single and multiple doses of MABT5102A
Secondary Outcome Measures
Pharmacokinetics of MABT5102A after single and multiple doses
Immunogenicity of MABT5102A after single and multiple doses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00736775
Brief Title
A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will be conducted in the United States and consists of a single ascending-dose stage followed by a multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult patients between 50-85 years old who have mild to moderate Alzheimer's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
AD, Alzheimer's, Alzheimers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
anti-Abeta
Intervention Description
Intravenous single and multiple doses
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Intravenous single and multiple doses
Primary Outcome Measure Information:
Title
Safety and tolerability of single and multiple doses of MABT5102A
Time Frame
Through study completion or early study discontinuation
Secondary Outcome Measure Information:
Title
Pharmacokinetics of MABT5102A after single and multiple doses
Time Frame
Through study completion or early study discontinuation
Title
Immunogenicity of MABT5102A after single and multiple doses
Time Frame
Through study completion or early study discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Ho, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease
We'll reach out to this number within 24 hrs