Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00359944 |
|
Recruitment Status :
Completed
First Posted : August 3, 2006
Results First Posted : July 2, 2013
Last Update Posted : July 2, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: AC-3933 Other: Sugar Pill | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 171 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Assessing the Efficacy and Safety of AC-3933 Tablets Twice Daily in Adults With Mild to Moderate Alzheimer's Disease |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | September 2008 |
| Actual Study Completion Date : | September 2008 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: AC-3933
AC-3933, 5mg twice daily
|
Drug: AC-3933
5mg twice daily |
|
Experimental: AC-3933, 20 mg twice daily
AC-3933, 20 mg twice daily
|
Drug: AC-3933
AC-3933, 20 mg twice daily |
|
Placebo Comparator: Placebo
Sugar Pill twice daily
|
Other: Sugar Pill
Sugar Pill twice daily
Other Name: Placebo |
- Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) [ Time Frame: Baseline to 16 weeks ]Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment.
- Clinicians Interview Based Impression of Change (CIBIC)-Plus [ Time Frame: Baseline to 16 weeks ]
Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment.
CIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end.
- Disability Assessment for Dementia (DAD) [ Time Frame: Baseline to 16 Weeks ]
Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores.
The DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Mild to moderate Alzheimer's Disease
- Male or female 55 years or older
- Living with caregiver
- Read, understand and speak English
Exclusion Criteria:
- Need to drive during the study
- Treatment with acetylcholinesterase inhibitors or NMDA antagonist, such as Aricept or Namenda, within 2 weeks of check-up and during the study
- Frequent Smoker
- Frequent Consumer of Caffeine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359944
Show 34 study locations
| Study Director: | Medical Director, MD | Sunovion |
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00359944 |
| Other Study ID Numbers: |
AC-3933-271 |
| First Posted: | August 3, 2006 Key Record Dates |
| Results First Posted: | July 2, 2013 |
| Last Update Posted: | July 2, 2013 |
| Last Verified: | May 2013 |
|
Alzheimer Dementia |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |