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

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

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00736775

Enrollment

Registered

2008-08-18

Start date

2008-08-31

Completion date

Unknown

Last updated

2010-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

AD, Alzheimer's, Alzheimers

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.

Interventions

DRUGanti-Abeta

Intravenous single and multiple doses

DRUGplacebo

Intravenous single and multiple doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 86 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026