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OpenTrials
Completed

NCT Number: NCT01343966

A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saibal Nandy Professional Corporation, Medicine Hat, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria
  • Mini-Mental State Examination (MMSE) score of 18-26 points at screening
  • Geriatric Depression Scale (GDS-15) score of < 6
  • Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)
  • If receiving concurrent AD treatment, patient must be on the medication for at least 3 months at a stable dose for at least 2 months prior to randomization.

Exclusion criteria

  • Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care
  • History or presence of clinically evident vascular disease potentially affecting the brain
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma
  • Hospitalization within 4 weeks prior to screening
  • Previous treatment with MABT5102A or any other therapeutic that targets Abeta
  • Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed

Treatment and study plan

MABT5102A

Drug

Repeating subcutaneous injection

Placebo

Drug

Repeating subcutaneous injection

Primary outcomes

  1. Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score

    Time frame: From baseline to Week 73

  2. Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score

    Time frame: From baseline to Week 73

Secondary outcomes

  1. Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score

    Time frame: From baseline to Week 73

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2011
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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