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Clinical Trials/EUCTR2006-004014-41-SE
EUCTR2006-004014-41-SE
Active, not recruiting
Not Applicable

A randomised, single-blind, placebo-controlled study to investigate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous infusion of GSK933776A in patients with Alzheimer’s disease

GlaxoSmithKline Research and Development0 sites122 target enrollmentOctober 3, 2006
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ConditionsMild Alzheimer's diseaseMedDRA version: 8.1Level: LLTClassification code 10001896Term: Alzheimer's disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Alzheimer's disease
Sponsor
GlaxoSmithKline Research and Development
Enrollment
122
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 3, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
GlaxoSmithKline Research and Development

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female subject with mild Alzheimer's Disease (AD) with MMSE score 18\-26 inclusive at the screening visit.
  • •2\. Age 55 to \= 80 years
  • •3\. Females must be post\-menopausal (i.e. \>24 months without menstrual period) or surgically sterile. Female subjects who have been post\-menopausal for \< 2 years must undertake pregnancy testing (ßhCG) at Visit 1, which must be negative and must use an adequate form of non\-hormonal contraceptive (e.g. barrier method).
  • •4\. Males whose partner is of child\-bearing potential or have been menopausal for \<2 years must use an adequate form of contraception (e.g. barrier method).
  • •5\. Subject has the ability to comply with procedures for cognitive and other testing, including MRI scans, and is fluent in the language used for the administration of the cognitive tests.
  • •6\. Subject lives with (or has substantial periods of contact with) a permanent caregiver who is willing to oversee the subject's compliance with protocol\-specified procedures and study medication, and report on subject's status.
  • •7\. Fluency in local language and evidence of adequate pre\-morbid intellectual functioning. Subject must have adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
  • •8\. In the opinion of the Investigator, the subject and the caregiver will be compliant and have a high probability of completing the study.
  • •9\. Subject has provided full written informed consent prior to the performance of any protocol\-specified procedure.
  • •10\. Caregiver has provided a full written informed consent on his/her own behalf prior to the performance of any protocol\-specified procedure.

Exclusion Criteria

  • •1\. History and/or evidence of any other central nervous system (CNS) disorder that could be interpreted as a cause of dementia
  • •2\. Hachinski Ischaemia Score \>4
  • •3\. Subjects currently living in a nursing home.
  • •4\. Subjects who are unable to provide informed consent due to cognitive status
  • •5\. Screening brain MRI with one or more of the following conditions:
  • •a) not consistent with AD
  • •b) has evidence of other CNS conditions listed in criterion 1
  • •c) shows more than minimal vascular changes
  • •d) shows more than 3 microhaemorrage lesions
  • •6\. Focal findings on the neurological exam (excluding changes attributable to peripheral injury or AD).

Outcomes

Primary Outcomes

Not specified

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