Alzheimer's DiseasePhase 2NCT00359944

Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease

A Phase 2 study testing AC-3933 and Sugar Pill in people with Alzheimer's Disease, run by Sumitomo Pharma America, Inc. at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Alzheimer's Disease
What is being tested?: AC-3933 and Sugar Pill
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 171 participants
Where: 34 sitesUnited States
Study dates: Feb 2006to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Mild to moderate Alzheimer's Disease
Male or female 55 years or older
Living with caregiver
Read, understand and speak English

Who cannot join

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

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Vertex Clinical Research
Bakersfield, California, 93311
Neurological Research Center, Inc.
Bennington, Vermont, 05201
East Bay Physicians Medical Grou[
Berkeley, California, 94705
Memory Disorder Clinic
Deerfield Beach, Florida, 33064
Odyssey Researcfh
Fargo, North Dakota, 58104
Precise Research Centers INc.
Flowood, Mississippi, 37232
Margolin Brain Institute
Fresno, California, 93720
Berma Research Group
Hialeah, Florida, 33016
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046
ClinicalStudies Center LLC
Little Rock, Arkansas, 72205
Clinical Trials Inc.
LIttle Rock, Alaska, 72205
UT Medical Group Inc.
Memphis, Tennessee, 38105
Advanced Research Institute of Miami
Miami, Florida, 33135
Research Institute of Miami
Miami, Florida, 33135
Research Center of Florida Inc.
Miami, Florida, 33173
Study site
Minneapolis, Minnesota, 53454
Clinical Trials Associates
Mission Viejo, California, 92691
Paradigm Research Professionals LLP
Oklahoma City, Oklahoma, 73112
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
University of California
Orange, California, 92868
Medical Research Group of Central Florida
Orange City, Florida, 32763
Compass Research LLC
Orlando, Florida, 32806
Four Rivers Clinical Research Inc.
Paducah, Kentucky, 42003
PsyPharma Clinical Research Inc.
Phoenix, Arizona, 85013
International Clinical Research Associates LLC
Richmond, Virginia, 23229
Clinical Psychopharmacology Consultants PA
Saint Louis Park, Minnesota, 55416
Pacific Research Network
San Diego, California, 92103
Psych Care Consultants Research
St Louis, Missouri, 63128
Internal Medicine Northwest
Tacoma, Washington, 98405
Department of Psychiatry and Behavioral Medicine
Tampa, Florida, 33613
Stedman Clinical Trials LLC
Tampa, Florida, 33613
Northern Michigan Neurology
Traverse City, Michigan, 49684
Tulsa Clinical Research LLC
Tulsa, Oklahoma, 74104
The Center for Excellence in Aging and Geriatric Health
Williamsburg, Virginia, 23185

Other trials in United States

About this study

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

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.

Conditions: Alzheimer's Disease
Being tested: AC-3933, Sugar Pill
Keywords: Alzheimer, Dementia
Medical subject headings: Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AC-3933Drug
5mg twice daily
AC-3933Drug
AC-3933, 20 mg twice daily
Sugar PillOther
Also called Placebo
Sugar Pill twice daily

Study groups in NCT00359944
Study group	Role	What they receive
AC-3933	Experimental	AC-3933, 5mg twice daily Receives: Drug: AC-3933
AC-3933, 20 mg twice daily	Experimental	AC-3933, 20 mg twice daily Receives: Drug: AC-3933
Placebo	Placebo comparator	Sugar Pill twice daily Receives: Other: Sugar Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 16 weeks

Secondary outcomes (2)

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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Sep 2008

First posted3 Aug 2006 (estimated)
Study startFeb 2006
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00359944
Sponsor's protocol ID: AC-3933-271
Status last verified: May 2013
First submitted: 1 Aug 2006
Last updated: 2 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00359944
Acronym / sponsor ID: AC-3933-271
Conditions: Alzheimer's Disease
Keywords: Alzheimer, Dementia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 171 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 3 Aug 2006 (estimated)
Results: Posted 2 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
AC-3933	Experimental	Drug: AC-3933AC-3933, 5mg twice daily
AC-3933, 20 mg twice daily	Experimental	Drug: AC-3933AC-3933, 20 mg twice daily
Placebo	Placebo comparator	Other: Sugar PillSugar Pill twice daily

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Mild to moderate Alzheimer's Disease
Male or female 55 years or older
Living with caregiver
Read, understand and speak English

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AC-39335mg twice daily	Drug	AC-3933
AC-3933AC-3933, 20 mg twice daily	Drug	AC-3933, 20 mg twice daily
Sugar PillAlso: PlaceboSugar Pill twice daily	Other	Placebo

Primary outcome

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.

2 secondary outcomes

Clinicians Interview Based Impression of Change (CIBIC)-Plus
Time frame: Baseline to 16 weeks
Disability Assessment for Dementia (DAD)
Time frame: Baseline to 16 Weeks

Results and safety

Results posted to the registry on 2 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AC-3933, 5 mg	50	34
AC-3933, 20 mg	47	28
Placebo	57	38

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	AC-3933, 5 mg n = 43	AC-3933, 20 mg n = 40	Placebo n = 49
Value	-1.3 (0.84)	-2.9 (0.88)	-1.5 (0.78)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: February 2006 to September 2008. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AC-3933, 5 mg	5 of 50 (10%)	11 of 50 (22%)	Not reported
AC-3933, 20 mg	4 of 46 (8.7%)	12 of 46 (26.1%)	Not reported
Placebo	5 of 58 (8.6%)	17 of 58 (29.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director, MD study director

Sumitomo Pharma America, Inc.

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AC-3933 and Sugar Pill in people with Alzheimer's Disease, run by Sumitomo Pharma America, Inc. at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00359944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.