Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient

NCT ID: NCT01424436

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-19
• Study Completion Date: 2011-12-08

Brief Summary

Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment

Detailed Description

This is a phase I, an open label, single dose and parallel group study to assess short term pharmacodynamics and safety of GSK933776. The effect on the beta amyloid levels will be assessed in early (MCI) and mild Alzheimer's disease (AD) patients after a single dose of GSK933776 by i.v. administration.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

GSK933776 1mg/kg

single dose

Group Type: EXPERIMENTAL

GSK933776

Intervention Type: BIOLOGICAL

1mg/kg dose group

GSK933776 0.1 or 3mg/kg

single dose

Group Type: EXPERIMENTAL

GSK933776

Intervention Type: BIOLOGICAL

3mg/kg dose group

GSK933776 3 or 6mg/kg

single dose

Group Type: EXPERIMENTAL

GSK933776

Intervention Type: BIOLOGICAL

6mg/kg dose group

Interventions

GSK933776

1mg/kg dose group

Intervention Type: BIOLOGICAL

GSK933776

3mg/kg dose group

Intervention Type: BIOLOGICAL

GSK933776

6mg/kg dose group

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Probable mild Alzheimer's disease (MMSE 20-26) or mild cognitive impairment
• Increase in total tau or p-tau in CSF
• Decrease in amyloid beta in CSF
• Stable dose of cholinesterase inhibitors, memantine or selegine or no treatment
• Body weight less than 120 kg
• Willingness to comply with contraceptive methods if self or partner is of child-bearing potential

Exclusion Criteria

• Any other cause of dementia
• Other significant neurologic or psychiatric illness
• Hachinski Ischemia Score >4
• More than 3 microbleeds on MRI
• Type 2 diabetes not controlled by diet
• Risk of cerebrovascular disease, cerebral haemorrhage or stroke
• History of systemic autoimmune disease
• Use of platelet anti-aggregates or anti-coagulants (Aspirin up to 325 mg/day is allowable)
• Use of chronic corticosteroids
• Uncontrolled hypertension in spite of antihypertensive medications
• Renal or hepatic insufficiency or clinically significant anaemia
• In nursing home care
• Contraindications to lumbar puncture or MRI
• Prior participation in therapeutic studies only after adequate wash-out period

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Aachen, North Rhine-Westphalia, Germany

GSK Investigational Site

Malmo, , Sweden

GSK Investigational Site

Stockholm, , Sweden

Countries

Germany; Sweden

References

Andreasen N, Simeoni M, Ostlund H, Lisjo PI, Fladby T, Loercher AE, Byrne GJ, Murray F, Scott-Stevens PT, Wallin A, Zhang YY, Bronge LH, Zetterberg H, Nordberg AK, Yeo AJ, Khan SA, Hilpert J, Mistry PC. First administration of the Fc-attenuated anti-beta amyloid antibody GSK933776 to patients with mild Alzheimer's disease: a randomized, placebo-controlled study. PLoS One. 2015 Mar 19;10(3):e0098153. doi: 10.1371/journal.pone.0098153. eCollection 2015.

Reference Type: DERIVED

PMID: 25789616 (View on PubMed)

Leyhe T, Andreasen N, Simeoni M, Reich A, von Arnim CA, Tong X, Yeo A, Khan S, Loercher A, Chalker M, Hottenstein C, Zetterberg H, Hilpert J, Mistry P. Modulation of beta-amyloid by a single dose of GSK933776 in patients with mild Alzheimer's disease: a phase I study. Alzheimers Res Ther. 2014 Apr 9;6(2):19. doi: 10.1186/alzrt249. eCollection 2014.

Reference Type: DERIVED

PMID: 24716469 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

113043

Identifier Type: -

Identifier Source: org_study_id