A Study of the Safety, Pharmacokinetics, Pharmacodynamics... | NCT00736775

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

NCT00736775

Sponsor

Genentech, Inc.

Status

Completed

Last Update Posted

Oct 27, 2010Estimated

Enrollment

56Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

anti-Abeta
placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

May 2010Actual

Completion Date

Not provided

First Submitted Date

Aug 15, 2008

First Submission Date that Met QC Criteria

Aug 15, 2008

First Posted Date

Aug 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2010

Last Update Posted Date

Oct 27, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anti-Abeta	Drug	Intravenous single and multiple doses
placebo	Drug	Intravenous single and multiple doses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of single and multiple doses of MABT5102A		Through study completion or early study discontinuation

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of MABT5102A after single and multiple doses		Through study completion or early study discontinuation
Immunogenicity of MABT5102A after single and multiple doses		Through study completion or early study discontinuation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

86 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Carole Ho, M.D.	Genentech, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided