Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease - Full Text View

Sponsored by:	Phytopharm
Information provided by:	Phytopharm
ClinicalTrials.gov Identifier:	NCT00130429

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 II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Memory

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

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

Locations

United Kingdom, Oxfordshire
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

Study ID Numbers:	P58/09ME/03/04
Study First Received:	August 12, 2005
Last Updated:	September 28, 2005
ClinicalTrials.gov Identifier:	NCT00130429
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Phytopharm:

dementia
memory
Hopkins verbal learning test
paired associated learning

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009