Alzheimer's Disease
Conditions
Keywords
Alzheimer, Dementia
Brief summary
The purpose of this study is to investigate efficacy and safety of different doses of AC-3933 in patients with mild to moderate Alzheimer's Disease.
Interventions
DRUGAC-3933
5mg twice daily
OTHERSugar Pill
Sugar Pill twice daily
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinicians Interview Based Impression of Change (CIBIC)-Plus | 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) | 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. |
Countries
United States
Participant flow
Pre-assignment details
17 patients were excluded from analysis because of QA issues at a study site.
Participants by arm
| Arm | Count |
|---|---|
| AC-3933 AC-3933, 5mg twice daily | 43 |
| AC-3933, 20 mg AC-3933, 20 mg twice daily | 40 |
| Placebo Sugar Pill twice daily | 49 |
| Total | 132 |
Baseline characteristics
| Characteristic | AC-3933, 20 mg | Placebo | AC-3933 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 49 Participants | 43 Participants | 132 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 74.8 years STANDARD_DEVIATION 9.54 | 76.3 years STANDARD_DEVIATION 8.73 | 75.5 years STANDARD_DEVIATION 8.57 | 75.6 years STANDARD_DEVIATION 8.88 |
| Region of Enrollment United States | 40 participants | 49 participants | 43 participants | 132 participants |
| Sex: Female, Male Female | 27 Participants | 38 Participants | 30 Participants | 95 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 13 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 50 | 12 / 46 | 17 / 58 |
| serious Total, serious adverse events | 5 / 50 | 4 / 46 | 5 / 58 |
Outcome results
Primary
Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)
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.
Time frame: Baseline to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AC-3933, 5 mg | Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) | -1.3 units on a scale | Standard Deviation 0.84 |
| AC-3933, 20 mg | Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) | -2.9 units on a scale | Standard Deviation 0.88 |
| Placebo | Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) | -1.5 units on a scale | Standard Deviation 0.78 |
Secondary
Clinicians Interview Based Impression of Change (CIBIC)-Plus
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.
Time frame: Baseline to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AC-3933, 5 mg | Clinicians Interview Based Impression of Change (CIBIC)-Plus | 4.1 units on a scale | Standard Deviation 0.97 |
| AC-3933, 20 mg | Clinicians Interview Based Impression of Change (CIBIC)-Plus | 3.9 units on a scale | Standard Deviation 1.11 |
| Placebo | Clinicians Interview Based Impression of Change (CIBIC)-Plus | 3.9 units on a scale | Standard Deviation 0.91 |
Secondary
Disability Assessment for Dementia (DAD)
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.
Time frame: Baseline to 16 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AC-3933, 5 mg | Disability Assessment for Dementia (DAD) | -2.7 units on a scale | Standard Deviation 1.89 |
| AC-3933, 20 mg | Disability Assessment for Dementia (DAD) | 4.0 units on a scale | Standard Deviation 2.1 |
| Placebo | Disability Assessment for Dementia (DAD) | 4.2 units on a scale | Standard Deviation 1.8 |