A Randomized, 18-Week, Placebo-Controlled, Double-Blind, Parallel Group Study Of The Safety And Efficacy Of PF-05212377 (SAM-760) In Subjects With Mild-To-Moderate Alzheimer's Disease With Existing Neuropsychiatric Symptoms On A Stable Daily Dose Of Donepezil
-
- STATUS
- Recruiting
Summary
A Randomized, 18-Week, Placebo-Controlled, Double-Blind, Parallel Group Study Of The Safety And Efficacy Of PF-05212377 (SAM-760) In Subjects With Mild-To-Moderate Alzheimer's Disease With Existing Neuropsychiatric Symptoms On A Stable Daily Dose Of Donepezil
Description
Patient Inclusion Criteria:
- Ages: over 60
- Male/Female
- 18 week long Clinical Trial
- Patient may not be full time permanent resident of nursing home
- Clinical diagnosis of probable AD with supportive brain imaging documentation
- Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10 on the NPI at screening, arising from item scores equal or greater than 2 (frequency X severity) on at least 2 domains.
- Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no intent to change such for the duration of the study.
Patient Exclusion Criteria:
- Demonstrate extreme agitation, physical aggression or violence to themselves, their caregiver, or others, and/or an inability to complete the ADAS-cog assessment at Screening
- Have major structural brain disease other than Alzheimer's Disease
- Other severe acute or chronical medical or psychiatric condition or laboratory abnormality
Details
| Clinical Study Identifier | TX136781 |
|---|---|
| Last Modified on | 8 December 2020 |
Eligibility
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer