NCT00736775

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Last Updated

October 27, 2010

Status Verified

October 1, 2010

Enrollment Period

1.7 years

First QC Date

August 15, 2008

Last Update Submit

October 26, 2010

Conditions

Alzheimer's Disease

Keywords

ADAlzheimer'sAlzheimers

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of single and multiple doses of MABT5102A

    Through study completion or early study discontinuation

Secondary Outcomes (2)

  • 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

Interventions

anti-AbetaDRUG

Intravenous single and multiple doses

placeboDRUG

Intravenous single and multiple doses

Eligibility Criteria

Age50 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Female patients with reproductive potential
  • History or presence of any clinically significant CNS disease
  • History of treatment with any protein therapeutic targeting Abeta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Carole Ho, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 18, 2008

Study Start

August 1, 2008

Primary Completion

May 1, 2010

Last Updated

October 27, 2010

Record last verified: 2010-10