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CompletedNCT00736775Updated Oct 27, 2010

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

A Phase 1 interventional study of anti-Abeta and placebo in Alzheimer's Disease, sponsored by Genentech, Inc.. Completed. Open to participants aged 50 Years to 86 Years. Per ClinicalTrials.gov, last updated 2010-10-27.

Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
50 Years to 86 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • AD
  • Alzheimer's
  • Alzheimers
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 56 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 86 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Interventions

  • Druganti-Abeta

    Intravenous single and multiple doses

  • Drugplacebo

    Intravenous single and multiple doses

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of single and multiple doses of MABT5102A

    Time frame: Through study completion or early study discontinuation

Secondary outcomes

  1. Pharmacokinetics of MABT5102A after single and multiple doses

    Time frame: Through study completion or early study discontinuation

  2. Immunogenicity of MABT5102A after single and multiple doses

    Time frame: Through study completion or early study discontinuation

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00736775
Lead sponsor
Genentech, Inc.
First posted
Aug 18, 2008
Start date
Aug 2008
Primary completion
May 2010
Last update
Oct 27, 2010

Study contacts

Carole Ho, M.D.
study director · Genentech, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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