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SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SUVN-502
Placebo
Donepezil
Memantine
Sponsored by
Suven Life Sciences Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring SUVN-502, 5-HT6, Phase 2, Cognition, Donepezil, Memantine, Alzheimer's Disease, Triple Combination, Proof of Concept (POC)

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria at least 1 year prior to the screening visit.
  • Has a score between 12 and 20 inclusive on the MMSE at the screening and baseline visits.
  • Has a MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease without any other clinically significant comorbid pathologies.
  • Must be receiving treatment with stable doses of donepezil HCl and memantine HCl for at least 3 months prior to the screening visit
  • Availability of an eligible and reliable caregiver
  • Must be living in the community or an assisted living facility.
  • Must be ambulatory or ambulatory aided (use of cane or walker).
  • Is not pregnant or planning to become pregnant during the study.
  • Subject (or subject's legally acceptable representative) and caregiver must sign an Informed Consent to participate in the study.

Exclusion Criteria:

  • Has a diagnosis of dementia due to other than Alzheimer's Disease
  • Is taking cholinesterase inhibitors other than donepezil HCl or taking doses of donepezil HCl other than 10 mg
  • Is taking doses of memantine HCl other than 10 mg bid or Namenda XR® 28 mg qd.
  • Has uncontrolled cardiac disease or hypertension.
  • Has clinically significant renal or hepatic impairment.
  • Has cancer or a malignant tumor, untreated thyroid disorder or has a history of seizure disorder
  • Is treated or likely to require treatment during the study, with any medications prohibited by the study protocol.

Sites / Locations

  • Banner Alzheimer's Institute
  • Barrow Neurological Institute
  • Territory Neurology & Research Institute
  • ATP Clinical Research, Inc.
  • Neuro-Pain Medical Center Inc
  • Neurology Center of North Orange County
  • Senior Clinical Trials, Inc.
  • Collaborative Neuroscience Network, LLC
  • Easton Center for Alzheimer's Disease Research at UCLA
  • Paradigm Research
  • Associated Neurologists of South Connecticut
  • JEM Research Institute
  • Bradenton Research Center, Inc
  • Brain Matters Research
  • Jacksonville Center for Clinical Research
  • CCM Clinical Research Group
  • Collier Neurologic Specialists
  • Palm Beach Neurological Center
  • Anchor Neuroscience
  • Emerald Coast Center for Neurological Disorders
  • Neurostudies Inc
  • The Roskamp Institute, Inc.
  • Brain Matters Research
  • Neurology Clinical Research, Inc.
  • Axiom Clinical Research of Florida
  • Olympian Clinical Research
  • Stedman Clinical Trials
  • University of South Florida - Byrd Alzheimer's Institute
  • iResearch Atlanta, LLC
  • Advocate Lutheran General Hospital
  • Southern Illinois School of Medicine
  • Indiana University Health - University Hospital
  • Cotton-O'Neil Clinical Research Center
  • KU Medical Center Wichita Clinical Trial Unit
  • University Of Kentucky
  • Pennington Biomedical Research Center
  • Acadia Hospital
  • Sheppard Pratt Health System
  • Clinical Research Professionals
  • Princeton Medical Institute
  • Advanced Memory Research Institute of NJ, PC - Internal Medicine
  • Advanced Memory Research Institute
  • Biobehavioral Health
  • Neurology Specialists of Monmouth County
  • Neurological Associates of Albany, PC
  • Integrative Clinical Trials, LLC
  • SPRI Clinical Trials, LLC
  • Mid Hudson Medical Research
  • New York University
  • Eastside Comprehensive Medical Center, LLC
  • Manhattan Behavioral Medicine
  • Upstate University Hospital (SUNY Health Science Center)
  • Five Towns Neuroscience Research
  • New Hope Clinical Research
  • Alzheimer Memory Center
  • Richard Weisler, MD, PA
  • Ohio Clinical Research Partners, LLC
  • Valley Medical Research
  • Cleveland Clinic Main Campus
  • IPS Research Company
  • Lynn Health Science Institute
  • Tulsa Clinical Research, LLC
  • Lehigh Valley Health Network
  • Northeastern Pennsylvania Memory and Alzheimers Center
  • Roper St. Francis Healthcare
  • University of North Texas Health Science Center
  • Shepherd Healthcare
  • Radiant Research, Inc.
  • Wasatch Clinical Research
  • Center for Alzheimer's Care, Imaging and Research
  • Independent Psychiatric Consultants, SC, dba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Experimental: SUVN-502 Low dose (50 mg)

Experimental: SUVN-502 High dose (100 mg)

Placebo

Arm Description

SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine

SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine

Placebo adjunct to base treatment with Donepezil and Memantine

Outcomes

Primary Outcome Measures

Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Mean change from baseline at week 26 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The scale ranges from 0 to 70, with higher scores indicate greater impairment.

Secondary Outcome Measures

Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory. The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.
Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory (NPI) 12 item - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders. Total score ranges from 12 to 144; higher scores indicate greater disease severity.
Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)
Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0, Maximum Score - 30. Higher score means better outcome.

Full Information

First Posted
October 17, 2015
Last Updated
May 16, 2023
Sponsor
Suven Life Sciences Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02580305
Brief Title
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
Official Title
A Phase 2a Multicenter, Randomized, Double-Blind, Parallel Group, 26-Week, Placebo-Controlled Study of SUVN-502 in Subjects With Moderate Alzheimer's Disease Currently Treated With Donepezil Hydrochloride and Memantine Hydrochloride
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
November 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suven Life Sciences Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable doses of donepezil HCl and memantine HCl.
Detailed Description
This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving donepezil HCl (10 mg qd) and either memantine HCl (10 mg twice daily [bid]) or Namenda XR® (Extended Release, 28 mg qd) or the combination therapy, Namzaric™ The primary objective of the study is to evaluate the efficacy of a serotonin receptor subtype 6 (5-HT6) antagonist, SUVN-502, compared to placebo, as adjunct treatment in subjects with moderate Alzheimer's disease (Mini-Mental State Examination [MMSE] score of 12 to 20) currently treated with the acetylcholinesterase inhibitor, donepezil hydrochloride (HCl), and the N-methyl-D-aspartic acid (NMDA) antagonist, memantine HCl. Efficacy will be assessed by the 11-item Alzheimer's Disease Assessment Scale for Cognitive Behavior (ADAScog-11) after 26 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
SUVN-502, 5-HT6, Phase 2, Cognition, Donepezil, Memantine, Alzheimer's Disease, Triple Combination, Proof of Concept (POC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
564 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: SUVN-502 Low dose (50 mg)
Arm Type
Active Comparator
Arm Description
SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine
Arm Title
Experimental: SUVN-502 High dose (100 mg)
Arm Type
Active Comparator
Arm Description
SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo adjunct to base treatment with Donepezil and Memantine
Intervention Type
Drug
Intervention Name(s)
SUVN-502
Other Intervention Name(s)
Masupirdine
Intervention Description
Once-daily, tablets, orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once-daily, tablets, orally
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Namzaric
Intervention Description
Donepezil HCl (10 mg, once a day)
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Namenda XR®
Intervention Description
Memantine HCl (10 mg, twice a day or 28 mg extended-release, once a day).
Primary Outcome Measure Information:
Title
Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Description
Mean change from baseline at week 26 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The scale ranges from 0 to 70, with higher scores indicate greater impairment.
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Description
Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Time Frame
Baseline to Week 26
Title
Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
Description
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory. The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.
Time Frame
Baseline to Week 26
Title
Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)
Description
Neuropsychiatric Inventory (NPI) 12 item - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders. Total score ranges from 12 to 144; higher scores indicate greater disease severity.
Time Frame
Baseline to Week 26
Title
Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)
Description
Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0, Maximum Score - 30. Higher score means better outcome.
Time Frame
Baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria at least 1 year prior to the screening visit. Has a score between 12 and 20 inclusive on the MMSE at the screening and baseline visits. Has a MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease without any other clinically significant comorbid pathologies. Must be receiving treatment with stable doses of donepezil HCl and memantine HCl for at least 3 months prior to the screening visit Availability of an eligible and reliable caregiver Must be living in the community or an assisted living facility. Must be ambulatory or ambulatory aided (use of cane or walker). Is not pregnant or planning to become pregnant during the study. Subject (or subject's legally acceptable representative) and caregiver must sign an Informed Consent to participate in the study. Exclusion Criteria: Has a diagnosis of dementia due to other than Alzheimer's Disease Is taking cholinesterase inhibitors other than donepezil HCl or taking doses of donepezil HCl other than 10 mg Is taking doses of memantine HCl other than 10 mg bid or Namenda XR® 28 mg qd. Has uncontrolled cardiac disease or hypertension. Has clinically significant renal or hepatic impairment. Has cancer or a malignant tumor, untreated thyroid disorder or has a history of seizure disorder Is treated or likely to require treatment during the study, with any medications prohibited by the study protocol.
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Territory Neurology & Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Neuro-Pain Medical Center Inc
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
72835
Country
United States
Facility Name
Senior Clinical Trials, Inc.
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Easton Center for Alzheimer's Disease Research at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Paradigm Research
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Associated Neurologists of South Connecticut
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Bradenton Research Center, Inc
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
CCM Clinical Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Collier Neurologic Specialists
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Palm Beach Neurological Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Anchor Neuroscience
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
Emerald Coast Center for Neurological Disorders
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Neurostudies Inc
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
The Roskamp Institute, Inc.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Brain Matters Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Facility Name
Neurology Clinical Research, Inc.
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University of South Florida - Byrd Alzheimer's Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Southern Illinois School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana University Health - University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
KU Medical Center Wichita Clinical Trial Unit
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University Of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Acadia Hospital
City
Bangor
State/Province
Maine
ZIP/Postal Code
04402
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Clinical Research Professionals
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Advanced Memory Research Institute of NJ, PC - Internal Medicine
City
Rahway
State/Province
New Jersey
ZIP/Postal Code
07065
Country
United States
Facility Name
Advanced Memory Research Institute
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Biobehavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Neurology Specialists of Monmouth County
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
Neurological Associates of Albany, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Integrative Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
SPRI Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Mid Hudson Medical Research
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Eastside Comprehensive Medical Center, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Upstate University Hospital (SUNY Health Science Center)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Five Towns Neuroscience Research
City
Woodmere
State/Province
New York
ZIP/Postal Code
11598
Country
United States
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Alzheimer Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Facility Name
Richard Weisler, MD, PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Ohio Clinical Research Partners, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Valley Medical Research
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Cleveland Clinic Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Tulsa Clinical Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Northeastern Pennsylvania Memory and Alzheimers Center
City
Plains
State/Province
Pennsylvania
ZIP/Postal Code
18705
Country
United States
Facility Name
Roper St. Francis Healthcare
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Shepherd Healthcare
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
Facility Name
Radiant Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Center for Alzheimer's Care, Imaging and Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Independent Psychiatric Consultants, SC, dba
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36168659
Citation
Nirogi R, Jayarajan P, Benade V, Shinde A, Goyal VK, Jetta S, Ravula J, Abraham R, Grandhi VR, Subramanian R, Pandey SK, Badange RK, Mohammed AR, Jasti V, Ballard C, Cummings J. Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses. Int J Geriatr Psychiatry. 2022 Oct;37(10):10.1002/gps.5813. doi: 10.1002/gps.5813.
Results Reference
result
PubMed Identifier
35662833
Citation
Nirogi R, Ieni J, Goyal VK, Ravula J, Jetta S, Shinde A, Jayarajan P, Benade V, Palacharla VRC, Dogiparti DK, Jasti V, Atri A, Cummings J. Effect of masupirdine (SUVN-502) on cognition in patients with moderate Alzheimer's disease: A randomized, double-blind, phase 2, proof-of-concept study. Alzheimers Dement (N Y). 2022 Jun 1;8(1):e12307. doi: 10.1002/trc2.12307. eCollection 2022.
Results Reference
result
PubMed Identifier
35908254
Citation
Nirogi R, Goyal VK, Benade V, Subramanian R, Ravula J, Jetta S, Shinde A, Pandey SK, Jayarajan P, Jasti V, Cummings J. Effect of Concurrent Use of Memantine on the Efficacy of Masupirdine (SUVN-502): A Post Hoc Analysis of a Phase 2 Randomized Placebo-Controlled Study. Neurol Ther. 2022 Dec;11(4):1583-1594. doi: 10.1007/s40120-022-00390-4. Epub 2022 Jul 31.
Results Reference
result
Links:
URL
https://doi.org/10.18103/mra.v10i9.3061
Description
Effect of Age, Cognitive Impairment Severity, and Duration of Disease on Efficacy of Masupirdine in Moderate Alzheimer's Disease Patients: A Post Hoc Analysis of a Phase-2 Randomized Placebo Controlled Study Results

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SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study

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