Alzheimer's DiseasePhase 2NCT00093951
SGS742 in Patients With Mild to Moderate Alzheimer's Disease (AD)
A Phase 2 study testing SGS742 in people with Alzheimer's Disease, run by Saegis Pharmaceuticals at 59 sites in United States.
Trial summary
The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and cognition in patients with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SGS742
- How many people
- 280 participants
- Where
- 59 sitesUnited States
- Study dates
- Apr 2004to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 to 90 years of age
- Diagnosed with mild to moderate Alzheimer's disease
- Willing caregiver
- In general good health
Who cannot join
- Call 1-877-MY-MEMORY and ask to be referred to a study center located near you for entry criteria information.
- Prohibited Meds:
- Alzheimer's medications (Aricept, Exelon, Remydl, Nemenda)
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 sites
Senior Adults Specialty Research, Inc.
Austin, Texas, 78757
Study site
Bala-Cynwyd, Pennsylvania, 19004
Claghorn-Lesem Research Clinic, Ltd.
Bellaire, Texas, 77401
Study site
Bennington, Vermont, 05201
Baumel-Eisner Neuromedical Institute, Inc.
Boca Raton, Florida, 33486
Bradenton Neurology, Inc.
Bradenton, Florida, 34205
MetroHealth Medical Center
Cleveland, Ohio, 44109
University Memory and Aging Center
Cleveland, Ohio, 44120
Research Center for Clinical Studies, Inc.
Darien, Connecticut, 06820
CSI Research
Decatur, Georgia, 30030
DeKalb Neurology Associates, LLC
Decatur, Georgia, 30033
Brain Matters, Inc.
Delray Beach, Florida, 33445
The Mile High Research Center
Denver, Colorado, 80218
RI Mood & Memory Research Institute
East Providence, Rhode Island, 02914
Oregon Center for Clinical Investigations, Inc.
Eugene, Oregon, 97401
Baumel-Eisner Neuromedical Institute
Fort Lauderdale, Florida, 33321
Margolin Brain Institute
Fresno, California, 93720
Berma Research Group
Hialeah, Florida, 33016
NervePro Research
Irvine, California, 92618
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
United Health Services Office of Clinical Trials
Johnson City, New York, 13790
Center for Neurologic Studies
La Jolla, California, 92037
SW Medical Associates
Las Vegas, Nevada, 89102
MidAmerica Neuroscience Institute
Lenexa, Kansas, 66214
Clinical Trials Incorporated
Little Rock, Arkansas, 72205
Study site
Madison, Tennessee, 37115
Study site
Medford, Oregon, 97504
Allied Clinical Trials, The Neurology Group
Miami, Florida, 33125
Tukoi Institute for Clinical Research
Miami, Florida, 33161
Baumel-Eisner Neuromedical Institute
Miami Beach, Florida, 33154
Study site
New York, New York, 10021
Ocala Neurodiagnostic Center
Ocala, Florida, 34471
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Study site
Orange City, Florida, 32763
Study site
Palm Springs, Florida, 33461
Neuro Therapeutics, Inc.
Pasadena, California, 91105
Study site
Paterson, New Jersey, 08759
Study site
Phoenix, Arizona, 85013
Study site
Pompano Beach, Florida, 33064
Psychopharmacology Research Association of Princeton, P.C.
Princeton, New Jersey, 08540
Raleigh Neurology
Raleigh, North Carolina, 27607
Study site
Raleigh, North Carolina, 27609
National Clinical Research, Inc.
Richmond, Virginia, 23294
Radiant Research San Antonio
San Antonio, Texas, 78229
Texas Medical Research Associates, LLC
San Antonio, Texas, 78238
Pacific Research Network, Inc.
San Diego, California, 92103
Affiliated Research Institute
San Diego, California, 92108
San Francisco Clinical Research Center
San Francisco, California, 94109
Southern California Clinical Research, Inc.
San Marino, California, 91108
Neurology Department, LSU Health Sciences Center
Shreveport, Louisiana, 71103
Baystate Medical Center
Springfield, Massachusetts, 01199
Study site
Stamford, Connecticut, 06902
Dedicated Clinical Research
Sun City, Arizona, 85351
Study site
Tampa, Florida, 33613
Study site
Tampa, Florida, 33647
Study site
Toledo, Ohio, 43623
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study of the Efficacy and Safety of SGS742 in Subjects With Mild to Moderate Alzheimer's Disease
The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and cognition in patients with mild to moderate Alzheimer's disease.
Read the detailed description
SGS742 is a GABA(B) receptor antagonist. It is an orally active drug and possesses neurochemical and psychopharmacologic features that suggest it could improve memory and cognition in humans. The primary objective of the SGS742 clinical trial will be to determine the effect of SGS742 on memory and cognition in individuals diagnosed with mild to moderate Alzheimer's disease. The duration of the study is 3 months with 5 clinic visits.
- Conditions
- Alzheimer's Disease
- Being tested
- SGS742
- Keywords
- Alzheimer disease, memory, cognition, GABA(B)receptor antagonist
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGS742Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2004 (estimated)
- Study startApr 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Enrolment
- 280 participants
Sponsor and investigators
- Lead sponsor
- Saegis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093951
- Sponsor's protocol ID
- IA0061
- Status last verified
- Feb 2009
- First submitted
- 7 Oct 2004
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
Froestl W, Gallagher M, Jenkins H, Madrid A, Melcher T, Teichman S, Mondadori CG, Pearlman R. SGS742: the first GABA(B) receptor antagonist in clinical trials. Biochem Pharmacol. 2004 Oct 15;68(8):1479-87. doi: 10.1016/j.bcp.2004.07.030.
PubMed 15451390
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study of the Efficacy and Safety of SGS742 in Subjects With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00093951
- Acronym / sponsor ID
- IA0061
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer disease, memory, cognition, GABA(B)receptor antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants
- Lead sponsor
- Saegis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 8 Oct 2004 (estimated)
- Results
- Not posted in the source record
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 trial is to determine the effect of a new drug, SGS742, on memory and cognition in patients with mild to moderate Alzheimer's disease.
Detailed description
SGS742 is a GABA(B) receptor antagonist. It is an orally active drug and possesses neurochemical and psychopharmacologic features that suggest it could improve memory and cognition in humans. The primary objective of the SGS742 clinical trial will be to determine the effect of SGS742 on memory and cognition in individuals diagnosed with mild to moderate Alzheimer's disease. The duration of the study is 3 months with 5 clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 55 to 90 years of age
- Diagnosed with mild to moderate Alzheimer's disease
- Willing caregiver
- In general good health
Key exclusion criteria (3 listed)
- Call 1-877-MY-MEMORY and ask to be referred to a study center located near you for entry criteria information.
- Alzheimer's medications (Aricept, Exelon, Remydl, Nemenda)
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 |
|---|---|---|
| SGS742 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Background: PubMed 15451390Froestl W, Gallagher M, Jenkins H, Madrid A, Melcher T, Teichman S, Mondadori CG, Pearlman R. SGS742: the first GABA(B) receptor antagonist in clinical trials. Biochem Pharmacol. 2004 Oct 15;68(8):1479-87. doi: 10.1016/j.bcp.2004.07.030.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
59 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 SGS742 in people with Alzheimer's Disease, run by Saegis Pharmaceuticals at 59 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 3 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 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00093951, which also lists 1 linked publication.
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 11 Dec 2009.