Phase II Multicenter 16-Week Randomized Double Blind Placebo-Controlled Evaluation of the Efficacy, Tolerability and Safety of Memantine Hydrochloride on Enhancing the Cognitive Abilities of Adolescents and Young Adults With Down Syndrome
Phase: PHASE2
Conditions: Down Syndrome, Intellectual Disability
Sponsor: University Hospitals Cleveland Medical Center

IRB Administration Offices
UH IRB Phone: 216.844.1529
CWRU IRB Phone: 216.368.6925 
The UH IRB operates under HHS Federalwide Assurance (FWA) number 00003937 and 
IRB registration numbers 00000684, 00001691 and 00008600. The CWRU IRB operates 
under DHHS FWA00004428 and IRB registration number 00000683.
HRP-510
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APPROVAL 
Principal Investigator:
Stephen Ruedrich
Title:
Phase II, Multicenter, Sixteen-Week, Randomized, Double 
Blind, Placebo-Controlled Evaluation of the Efficacy, 
Tolerability and Safety of Memantine Hydrochloride on 
Enhancing the Cognitive Abilities of Adolescents and Young 
Adults with Down Syndrome
IRB Number:
06-14-41.
Submission Number:
MODCR00001477
IRB Office:
UH IRB
Approval Date:
6/6/2021
Effective Date:
6/6/2021
Approval End Date:
6/5/2022
Type of Submission:
Modification and Continuing Review
Type of Review:
Expedited
Documents Reviewed:
• Alana-Memantine-High-Density-EEG-MRI-Consent 7-2-
2020.pdf, Category: Consent Form;
• Costa Protocol 7-9-2020, Category: IRB Protocol;
• Alana-Memantine-Assent 1-22-19.pdf, Category: Consent 
Form;
• Informed Consent Chicago 7-2-2020.pdf, Category: 
Consent Form;
• Alana-Memantine-MRI-Consent 7-2-2020.pdf, Category: 
Consent Form;
• Informed Consent 7-2-2020.pdf, Category: Consent Form;
The IRB reviewed this submission.

Per Federal regulation, changes MAY NOT be made to any element of the current 
research without prior IRB approval, except to eliminate an immediate and apparent 
hazard to subjects enrolled in the study.

Per Federal regulation, the research may not continue beyond the Approval End 
date. You must submit a continuing review form 6-8 weeks before this Approval End 
date in order to maintain IRB approval. Failure to maintain IRB approval is human 
subjects non-compliance.  Please note that even if your study falls into a category that 

IRB Administration Offices
UH IRB Phone: 216.844.1529
CWRU IRB Phone: 216.368.6925 
The UH IRB operates under HHS Federalwide Assurance (FWA) number 00003937 and 
IRB registration numbers 00000684, 00001691 and 00008600. The CWRU IRB operates 
under DHHS FWA00004428 and IRB registration number 00000683.
HRP-510
Page 2 of 2
does not require an Approval End date, the institution may require a yearly “check-
in” to confirm the status of the study.  
***Approval by the IRB does NOT mean that you have permission to start your study. 
Prior to starting your study, you may be required to obtain (1) a coverage analysis for 
studies that involve patient care, regardless of source of funding, and/or (2) a contract 
with the Sponsor of your study or an agreement with any third-party collaborator that 
may receive UH or CWRU patient information in any format. Please ensure that all 
required approvals are obtained before initiation of research activity. ***