Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Phytopharm
ClinicalTrials.gov Identifier:
NCT00130429
First received: August 12, 2005
Last updated: August 20, 2009
Last verified: August 2009
  Purpose

The purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease.


Condition Intervention Phase
Alzheimer's Disease
Drug: PYM50028
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase II Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Effect on Cognition and Pharmacokinetic Profile of PYM50028 in Subjects With Mild Dementia of the Alzheimer's Type

Resource links provided by NLM:


Further study details as provided by Phytopharm:

Primary Outcome Measures:
  • Hopkins verbal learning test (revised) total word recall after 12 weeks
  • Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks

Secondary Outcome Measures:
  • Mini mental state examination score
  • Clinical dementia rating (overall and sum of boxes)
  • CANTAB rapid visual information processing (RVIP) mean latency
  • CANTAB RVIP total correct hits
  • CANTAB spatial working memory within error, between error and strategy scores
  • Clinicians global impression of change
  • Disability assessment for dementia score

Estimated Enrollment: 250
Study Start Date: January 2004
Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 50 years of age
  • Diagnosis of possible or probable Alzheimer's disease
  • Mini mental state examination score at least 16
  • Good understanding of both written and verbal English
  • A recent head scan that is consistent with the diagnosis of Alzheimer's disease

Exclusion Criteria:

  • Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease
  • Known to have another condition that is associated with dementia
  • Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine)
  • Hormone replacement therapy started or changed within the previous 6 months
  • Received any investigational drugs within the previous 12 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130429

Locations
United Kingdom
Oxford Project to Investigate Memory and Ageing
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Sponsors and Collaborators
Phytopharm
Investigators
Principal Investigator: Robin Jacoby, FRCPsych University of Oxford, UK
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00130429     History of Changes
Other Study ID Numbers: P58/09ME/03/04
Study First Received: August 12, 2005
Last Updated: August 20, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Phytopharm:
dementia
memory
Hopkins verbal learning test
paired associated learning

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 22, 2014