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Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial
Our previous studies showed that GV1001 has various protective effects against β-amyloid and other stressors. Based on these findings, we hypothesized that GV1001 might have beneficial effects in patients with Alzheimer's disease (AD). A phase 2, double-blind, parallel-group, placebo-controlled...
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| Published in: | Alzheimer's research & therapy 2021-03, Vol.13 (1), p.66-66, Article 66 |
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| creator | Koh, Seong-Ho Kwon, Hyuk Sung Choi, Seong Hye Jeong, Jee Hyang Na, Hae Ri Lee, Chan Nyoung Yang, YoungSoon Lee, Ae Young Lee, Jae-Hong Park, Kyung Won Han, Hyun Jeong Kim, Byeong C Park, Jin Se Lee, Jee-Young Kim, Sangjae Lee, Kyu-Yong |
| description | Our previous studies showed that GV1001 has various protective effects against β-amyloid and other stressors. Based on these findings, we hypothesized that GV1001 might have beneficial effects in patients with Alzheimer's disease (AD).
A phase 2, double-blind, parallel-group, placebo-controlled, 6-month randomized clinical trial was performed to evaluate the safety and efficacy of subcutaneously administered GV1001. Between September 2017 and September 2019, 13 centers in South Korea recruited participants. A total of 106 patients were screened, and 96 patients with moderate-to-severe AD were randomized 1:1:1 to the placebo (group 1, n = 31), GV1001 0.56 mg (group 2, n = 33), and 1.12 mg (group 3, n = 32) groups. GV1001 was administered every week for 4 weeks (4 times), followed by every 2 weeks until week 24 (10 times). The primary endpoint was the change in the Severe Impairment Battery (SIB) score from baseline to week 24. The key secondary efficacy endpoints were the change in the Clinical Dementia Rating Sum of Box (CDR-SOB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI), Mini-Mental State Examination, and Global Deterioration Scale scores. The safety endpoints were also assessed based on adverse events, laboratory test results, vital signs, and other observations related to safety.
Group 3 showed less decrease in the SIB score at 12 and 24 weeks compared with group 1 (P |
| doi_str_mv | 10.1186/s13195-021-00803-w |
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A phase 2, double-blind, parallel-group, placebo-controlled, 6-month randomized clinical trial was performed to evaluate the safety and efficacy of subcutaneously administered GV1001. Between September 2017 and September 2019, 13 centers in South Korea recruited participants. A total of 106 patients were screened, and 96 patients with moderate-to-severe AD were randomized 1:1:1 to the placebo (group 1, n = 31), GV1001 0.56 mg (group 2, n = 33), and 1.12 mg (group 3, n = 32) groups. GV1001 was administered every week for 4 weeks (4 times), followed by every 2 weeks until week 24 (10 times). The primary endpoint was the change in the Severe Impairment Battery (SIB) score from baseline to week 24. The key secondary efficacy endpoints were the change in the Clinical Dementia Rating Sum of Box (CDR-SOB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI), Mini-Mental State Examination, and Global Deterioration Scale scores. The safety endpoints were also assessed based on adverse events, laboratory test results, vital signs, and other observations related to safety.
Group 3 showed less decrease in the SIB score at 12 and 24 weeks compared with group 1 (P < 0.05). These were not significantly observed in group 2. Among the secondary endpoints, only the NPI score showed significantly better improvement in group 2 than in group 3 at week 12; however, there were no other significant differences between the groups. Although the ADCS-ADL and CDR-SOB scores showed a pattern similar to SIB scores, a statistically significant result was not found. Adverse events were similar across all three groups.
The results indicate that GV1001 1.12 mg met the primary endpoint of a statistically significant difference. GV1001 was well tolerated without safety concerns. This study warrants a larger clinical trial.
ClinicalTrials.gov NCT03184467 . Registered on June 12, 2017.</description><identifier>ISSN: 1758-9193</identifier><identifier>EISSN: 1758-9193</identifier><identifier>DOI: 10.1186/s13195-021-00803-w</identifier><identifier>PMID: 33771205</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Activities of daily living ; Alzheimer's disease ; Amyloid beta-protein ; Care and treatment ; Clinical trial ; Clinical trials ; Dementia ; Development and progression ; Double-blind studies ; Drug dosages ; Efficacy ; Evaluation ; FDA approval ; Gene expression ; Genetic aspects ; GV1001 ; Health aspects ; Magnetic resonance imaging ; Safety</subject><ispartof>Alzheimer's research & therapy, 2021-03, Vol.13 (1), p.66-66, Article 66</ispartof><rights>COPYRIGHT 2021 BioMed Central Ltd.</rights><rights>2021. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c594t-311f52067bac5b45756188f7083269cc406feb06a37805c226d563fef39991af3</citedby><cites>FETCH-LOGICAL-c594t-311f52067bac5b45756188f7083269cc406feb06a37805c226d563fef39991af3</cites><orcidid>0000-0001-5419-5761</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7995588/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2514800588?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33771205$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Koh, Seong-Ho</creatorcontrib><creatorcontrib>Kwon, Hyuk Sung</creatorcontrib><creatorcontrib>Choi, Seong Hye</creatorcontrib><creatorcontrib>Jeong, Jee Hyang</creatorcontrib><creatorcontrib>Na, Hae Ri</creatorcontrib><creatorcontrib>Lee, Chan Nyoung</creatorcontrib><creatorcontrib>Yang, YoungSoon</creatorcontrib><creatorcontrib>Lee, Ae Young</creatorcontrib><creatorcontrib>Lee, Jae-Hong</creatorcontrib><creatorcontrib>Park, Kyung Won</creatorcontrib><creatorcontrib>Han, Hyun Jeong</creatorcontrib><creatorcontrib>Kim, Byeong C</creatorcontrib><creatorcontrib>Park, Jin Se</creatorcontrib><creatorcontrib>Lee, Jee-Young</creatorcontrib><creatorcontrib>Kim, Sangjae</creatorcontrib><creatorcontrib>Lee, Kyu-Yong</creatorcontrib><title>Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial</title><title>Alzheimer's research & therapy</title><addtitle>Alzheimers Res Ther</addtitle><description>Our previous studies showed that GV1001 has various protective effects against β-amyloid and other stressors. Based on these findings, we hypothesized that GV1001 might have beneficial effects in patients with Alzheimer's disease (AD).
A phase 2, double-blind, parallel-group, placebo-controlled, 6-month randomized clinical trial was performed to evaluate the safety and efficacy of subcutaneously administered GV1001. Between September 2017 and September 2019, 13 centers in South Korea recruited participants. A total of 106 patients were screened, and 96 patients with moderate-to-severe AD were randomized 1:1:1 to the placebo (group 1, n = 31), GV1001 0.56 mg (group 2, n = 33), and 1.12 mg (group 3, n = 32) groups. GV1001 was administered every week for 4 weeks (4 times), followed by every 2 weeks until week 24 (10 times). The primary endpoint was the change in the Severe Impairment Battery (SIB) score from baseline to week 24. The key secondary efficacy endpoints were the change in the Clinical Dementia Rating Sum of Box (CDR-SOB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI), Mini-Mental State Examination, and Global Deterioration Scale scores. The safety endpoints were also assessed based on adverse events, laboratory test results, vital signs, and other observations related to safety.
Group 3 showed less decrease in the SIB score at 12 and 24 weeks compared with group 1 (P < 0.05). These were not significantly observed in group 2. Among the secondary endpoints, only the NPI score showed significantly better improvement in group 2 than in group 3 at week 12; however, there were no other significant differences between the groups. Although the ADCS-ADL and CDR-SOB scores showed a pattern similar to SIB scores, a statistically significant result was not found. Adverse events were similar across all three groups.
The results indicate that GV1001 1.12 mg met the primary endpoint of a statistically significant difference. GV1001 was well tolerated without safety concerns. This study warrants a larger clinical trial.
ClinicalTrials.gov NCT03184467 . Registered on June 12, 2017.</description><subject>Activities of daily living</subject><subject>Alzheimer's disease</subject><subject>Amyloid beta-protein</subject><subject>Care and treatment</subject><subject>Clinical trial</subject><subject>Clinical trials</subject><subject>Dementia</subject><subject>Development and progression</subject><subject>Double-blind studies</subject><subject>Drug dosages</subject><subject>Efficacy</subject><subject>Evaluation</subject><subject>FDA approval</subject><subject>Gene expression</subject><subject>Genetic aspects</subject><subject>GV1001</subject><subject>Health aspects</subject><subject>Magnetic resonance imaging</subject><subject>Safety</subject><issn>1758-9193</issn><issn>1758-9193</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNptkk1v1DAQhiMEoqXwBzggS0jAgRR_xInTA1JVlVKpEhfgak2c8a4rJ17spKvt_-N_4e2WqouQD_565p3x-C2K14weM6bqT4kJ1sqSclZSqqgo10-KQ9ZIVbasFU8frQ-KFyldU1rXXFXPiwMhmoZxKg-L3-fWOgNmQ2DsSQKL04YESy5-MkoZcSNZweRwnBJZu2lJhtBjhAnLKZQJbzAiOfW3S3QDxveJ9C4hJCTgI0K_IRENuhs3LkgfRlzhrfMnBMhquYU4iTlpGNwt9h8zMHcey867Me9WHgx2oTRhnGLwfksMs5-cybVgJCZjuW5PpujAvyyeWfAJX93PR8WPL-ffz76WV98uLs9Or0oj22oqBWNWclo3HRjZVbKRNVPKNlQJXrfGVLS22NEaRKOoNJzXvayFRSvatmVgxVFxudPtA1zrVXQDxI0O4PTdQYgLDTHX6FE3pqqazsrKcKgkawFE3wNXIvc9JxdZ6_NOazV3A_bbd0Xwe6L7N6Nb6kW40U3bSqlUFvhwLxDDrxnTpAeXDHoPI4Y5aS5pzRslaJXRt_-g12GOY25VplilKN0J3lMLyA9wow05r9mK6tNaNrxmrdpqHf-HyqPHweXvQuvy-V7Au0cBSwQ_LVPw8-TCmPZBvgNNDClFtA_NYFRvHa93jtfZ8frO8Xqdg948buNDyF-Liz-XSfyM</recordid><startdate>20210326</startdate><enddate>20210326</enddate><creator>Koh, Seong-Ho</creator><creator>Kwon, Hyuk Sung</creator><creator>Choi, Seong Hye</creator><creator>Jeong, Jee Hyang</creator><creator>Na, Hae Ri</creator><creator>Lee, Chan Nyoung</creator><creator>Yang, YoungSoon</creator><creator>Lee, Ae Young</creator><creator>Lee, Jae-Hong</creator><creator>Park, Kyung Won</creator><creator>Han, Hyun Jeong</creator><creator>Kim, Byeong C</creator><creator>Park, Jin Se</creator><creator>Lee, Jee-Young</creator><creator>Kim, Sangjae</creator><creator>Lee, Kyu-Yong</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><general>BMC</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0001-5419-5761</orcidid></search><sort><creationdate>20210326</creationdate><title>Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial</title><author>Koh, Seong-Ho ; Kwon, Hyuk Sung ; Choi, Seong Hye ; Jeong, Jee Hyang ; Na, Hae Ri ; Lee, Chan Nyoung ; Yang, YoungSoon ; Lee, Ae Young ; Lee, Jae-Hong ; Park, Kyung Won ; Han, Hyun Jeong ; Kim, Byeong C ; Park, Jin Se ; Lee, Jee-Young ; Kim, Sangjae ; Lee, Kyu-Yong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c594t-311f52067bac5b45756188f7083269cc406feb06a37805c226d563fef39991af3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Activities of daily living</topic><topic>Alzheimer's disease</topic><topic>Amyloid beta-protein</topic><topic>Care and treatment</topic><topic>Clinical trial</topic><topic>Clinical trials</topic><topic>Dementia</topic><topic>Development and progression</topic><topic>Double-blind studies</topic><topic>Drug dosages</topic><topic>Efficacy</topic><topic>Evaluation</topic><topic>FDA approval</topic><topic>Gene expression</topic><topic>Genetic aspects</topic><topic>GV1001</topic><topic>Health aspects</topic><topic>Magnetic resonance imaging</topic><topic>Safety</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Koh, Seong-Ho</creatorcontrib><creatorcontrib>Kwon, Hyuk Sung</creatorcontrib><creatorcontrib>Choi, Seong Hye</creatorcontrib><creatorcontrib>Jeong, Jee Hyang</creatorcontrib><creatorcontrib>Na, Hae Ri</creatorcontrib><creatorcontrib>Lee, Chan Nyoung</creatorcontrib><creatorcontrib>Yang, YoungSoon</creatorcontrib><creatorcontrib>Lee, Ae Young</creatorcontrib><creatorcontrib>Lee, Jae-Hong</creatorcontrib><creatorcontrib>Park, Kyung Won</creatorcontrib><creatorcontrib>Han, Hyun Jeong</creatorcontrib><creatorcontrib>Kim, Byeong C</creatorcontrib><creatorcontrib>Park, Jin Se</creatorcontrib><creatorcontrib>Lee, Jee-Young</creatorcontrib><creatorcontrib>Kim, Sangjae</creatorcontrib><creatorcontrib>Lee, Kyu-Yong</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Alzheimer's research & therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Koh, Seong-Ho</au><au>Kwon, Hyuk Sung</au><au>Choi, Seong Hye</au><au>Jeong, Jee Hyang</au><au>Na, Hae Ri</au><au>Lee, Chan Nyoung</au><au>Yang, YoungSoon</au><au>Lee, Ae Young</au><au>Lee, Jae-Hong</au><au>Park, Kyung Won</au><au>Han, Hyun Jeong</au><au>Kim, Byeong C</au><au>Park, Jin Se</au><au>Lee, Jee-Young</au><au>Kim, Sangjae</au><au>Lee, Kyu-Yong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial</atitle><jtitle>Alzheimer's research & therapy</jtitle><addtitle>Alzheimers Res Ther</addtitle><date>2021-03-26</date><risdate>2021</risdate><volume>13</volume><issue>1</issue><spage>66</spage><epage>66</epage><pages>66-66</pages><artnum>66</artnum><issn>1758-9193</issn><eissn>1758-9193</eissn><abstract>Our previous studies showed that GV1001 has various protective effects against β-amyloid and other stressors. Based on these findings, we hypothesized that GV1001 might have beneficial effects in patients with Alzheimer's disease (AD).
A phase 2, double-blind, parallel-group, placebo-controlled, 6-month randomized clinical trial was performed to evaluate the safety and efficacy of subcutaneously administered GV1001. Between September 2017 and September 2019, 13 centers in South Korea recruited participants. A total of 106 patients were screened, and 96 patients with moderate-to-severe AD were randomized 1:1:1 to the placebo (group 1, n = 31), GV1001 0.56 mg (group 2, n = 33), and 1.12 mg (group 3, n = 32) groups. GV1001 was administered every week for 4 weeks (4 times), followed by every 2 weeks until week 24 (10 times). The primary endpoint was the change in the Severe Impairment Battery (SIB) score from baseline to week 24. The key secondary efficacy endpoints were the change in the Clinical Dementia Rating Sum of Box (CDR-SOB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI), Mini-Mental State Examination, and Global Deterioration Scale scores. The safety endpoints were also assessed based on adverse events, laboratory test results, vital signs, and other observations related to safety.
Group 3 showed less decrease in the SIB score at 12 and 24 weeks compared with group 1 (P < 0.05). These were not significantly observed in group 2. Among the secondary endpoints, only the NPI score showed significantly better improvement in group 2 than in group 3 at week 12; however, there were no other significant differences between the groups. Although the ADCS-ADL and CDR-SOB scores showed a pattern similar to SIB scores, a statistically significant result was not found. Adverse events were similar across all three groups.
The results indicate that GV1001 1.12 mg met the primary endpoint of a statistically significant difference. GV1001 was well tolerated without safety concerns. This study warrants a larger clinical trial.
ClinicalTrials.gov NCT03184467 . Registered on June 12, 2017.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>33771205</pmid><doi>10.1186/s13195-021-00803-w</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0001-5419-5761</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Activities of daily living Alzheimer's disease Amyloid beta-protein Care and treatment Clinical trial Clinical trials Dementia Development and progression Double-blind studies Drug dosages Efficacy Evaluation FDA approval Gene expression Genetic aspects GV1001 Health aspects Magnetic resonance imaging Safety |
| title | Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial |
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