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

NCT ID: NCT00130429

Last Updated: 2009-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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PYM50028

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phytopharm

INDUSTRY

Sponsor Role lead

Principal Investigators

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Robin Jacoby, FRCPsych

Role: PRINCIPAL_INVESTIGATOR

University of Oxford, UK

Locations

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Oxford Project to Investigate Memory and Ageing

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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P58/09ME/03/04

Identifier Type: -

Identifier Source: org_study_id

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