Overview

SB-742457 And Donepezil In Alzheimer's Disease

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's Disease.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Donepezil
Criteria
Inclusion criteria:

- Clinical diagnosis of probable mild-to-moderate Alzheimer's Disease as determined by
the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24.

- Subjects and their caregivers must provide informed consent prior to study entry.

- Adequate blood pressure and laboratory values.

Exclusion criteria:

- Females of child-bearing potential.

- Have other causes of dementia such as vascular damage, depression, bipolar affective
disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.

- Subjects taking medication for Alzheimers disease or centrally acting agents which
might impact study outcomes.

- Subjects taking agents for which there is a theoretical risk of interaction with
SB-742457 or donepezil.

- Subjects with conditions which might be exacerbated by exposure to donepezil.

- Subjects with known hypersensitivity to sunlight or seizures.