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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2214-004 | Other Identifier | MSD | |
| 2024-519190-19-00 | Registry Identifier | EU CT | |
| U1111-1314-8296 | Registry Identifier | UTN | |
| jRCT2031250299 | Registry Identifier | Japan Registry of Clinical Trial (jRCT) |
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Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD.
The goals of the study are to learn:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-2214 | Experimental | Participants will receive MK-2214 via intravenous (IV) infusion every 4 weeks (q4w) during the study. |
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| Placebo | Placebo Comparator | Participants will receive a placebo via IV infusion q4w during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2214 | Biological | IV infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr) | Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD & damages brain cells. SUVr is SUV in the region of interest divided by SUV in a reference region (cerebellum). The change from baseline in tau PET SUVr will be reported. | Baseline, up to approximately 23 months |
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience one or more AEs will be reported. | Up to approximately 26 months |
| Number of Participants Who Discontinue Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE will be reported. | Up to approximately 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) Total Score | The CDR-SB is used for cognitive assessment in people with AD. The CDR is a clinical scale that describes 5 degrees of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia CDR score ranging from 0 (normal) to 3 (severe). A total score is calculated as the sum of the category scores, with a range of 0 (normal) to 18 (severe). Higher scores indicate more impairment. The change from baseline in CDR-SB total score will be reported. |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irvine Clinical Research ( Site 1041) | Recruiting | Irvine | California | 92614 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Drug |
IV infusion |
|
| Baseline, up to approximately 23 months |
| Change from Baseline in the Composite Tau PET SUVr in Braak Region III and IV | Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD & damages brain cells. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). Braak staging ranges from Braak I to VI. Description for Braak III includes amygdala, parahippocampal gyrus, fusiform gyrus, & lingual gyrus, and Braak IV includes insula, inferior temporal, lateral temporal, posterior cingulate, & inferior parietal. The composite tau PET SUVr is a weighted average of tau PET SUVr values obtained from multiple brain regions, with weights being the percentage volume of each region within the composite. The change from baseline in composite tau PET SUVr in Braak regions III and IV will be reported. | Baseline, up to approximately 23 months |
| Change from Baseline in the Composite Tau PET SUVr | Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD & damages brain cells. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). The composite tau PET SUVr is a weighted average of tau PET SUVr values obtained from multiple brain regions, with weights being the percentage volume of each region within the composite. The change from baseline in composite tau PET SUVr will be reported. | Baseline, up to approximately 23 months |
| Change from Baseline in the Composite Tau PET SUVr in Braak Region I to VI | Participants will have tau PET imaging to assess tau (protein that accumulates in AD & damages brain cells) pathology. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). Braak staging ranges from I-VI (Braak I (transentorhinal); II (entorhinal & hippocampus); III (amygdala, parahippocampal gyrus, fusiform gyrus, & lingual gyrus); IV (insula, inferior temporal, lateral temporal, posterior cingulate, & inferior parietal); V (orbitofrontal, superior temporal, inferior frontal, cuneus, anterior cingulate, supramarginal gyrus, lateral occipital, precuneus, superior parietal, superior frontal, & rostro medial frontal); VI (paracentral, postcentral, precentral, & pericalcarine)). Composite tau PET SUVr is weighted average of tau PET SUVr values from multiple brain regions, with weights being percentage volume of each region. The change from baseline in composite tau PET SUVr in Braak region I to IV will be reported. | Baseline, up to approximately 23 months |
| Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale13 (ADAS-Cog13) Total Score | The ADAS-Cog13 is a structured scale that evaluates memory (word recall, delayed word recall, and word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). In addition, ratings of spoken language, language comprehension, word finding difficulty, ability to remember test instructions, and number cancellation will be obtained. Per protocol, score range will be from 0 (no impairment) to 85 (maximum impairment) points. Higher scores indicate more impairment. The change from baseline in ADAS-Cog13 total score will be reported. | Baseline, up to approximately 23 months |
| Change from Baseline in the Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL-MCI) Total Score | ADCS-ADL-MCI evaluates the ability of individuals to perform various daily activities including basic activities of daily living (BADL; personal care tasks like bathing, dressing and eating) and instrumental activities of daily living (IADL; complex tasks such as managing finances, preparing meals, using telephone) administered through caregiver or family member to access severity of cognitive decline in the past 4 weeks. Each item is scored on a scale of 0 (unable to do) to 2 (independent). The total score is calculated by summing scores of all items and ranges from 0 (poor functioning) to 68 (better functioning). Higher scores indicate better functional ability. The change from baseline in ADCS-ADL-MCI total score will be reported. | Baseline, up to approximately 23 months |
| Change from Baseline in Modified Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score | The modified iADRS is a composite tool to measure cognition and function. The modified iADRS is a linear combination of total scores from the ADAS-Cog and the ADCS-ADL-MCI. The modified iADRS composite score is calculated by subtracting the ADAS-Cog13 score from 85 and then adding the ADCS-ADL-MCI score. Composite score ranges from 0 (maximum impairment) to 144 (greater independent, healthy functioning and cognition). Lower scores indicate more impairment. The change from baseline in modified iADRS total score will be reported. | Baseline, up to approximately 23 months |
| Healthy Brain Clinic ( Site 1005) | Recruiting | Long Beach | California | 90804 | United States |
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| Inglewood Clinical ( Site 1062) | Recruiting | Los Angeles | California | 90056 | United States |
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| Anderson Clinical Research ( Site 1024) | Recruiting | Redlands | California | 92374 | United States |
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| UCSF Memory and Aging Center ( Site 1031) | Recruiting | San Francisco | California | 94158 | United States |
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| Syrentis Clinical Research ( Site 1001) | Recruiting | Santa Ana | California | 92705 | United States |
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| Yale University, Alzheimer's Disease Research Unit ( Site 1059) | Recruiting | New Haven | Connecticut | 06510 | United States |
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| JEM Research Institute ( Site 1046) | Recruiting | Atlantis | Florida | 33462 | United States |
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| Neuropsychiatric Research Center of Southwest Florida ( Site 1003) | Recruiting | Fort Myers | Florida | 33912 | United States |
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| K2 Medical Research ( Site 1047) | Recruiting | Maitland | Florida | 32750 | United States |
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| ClinCloud LLC ( Site 1039) | Recruiting | Melbourne | Florida | 32940 | United States |
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| Indago Research and Health Center Inc ( Site 1044) | Recruiting | Miami Lakes | Florida | 33016 | United States |
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| Aqualane Clinical Research ( Site 1035) | Recruiting | Naples | Florida | 34105 | United States |
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| Suncoast Clinical Research ( Site 1007) | Recruiting | New Port Richey | Florida | 34652 | United States |
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| Renstar Medical Research ( Site 1012) | Recruiting | Ocala | Florida | 34471 | United States |
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| Charter Research - Orlando ( Site 1051) | Recruiting | Orlando | Florida | 32803 | United States |
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| Axiom Brain Health ( Site 1029) | Recruiting | Tampa | Florida | 33609 | United States |
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| K2 Medical Research ( Site 1020) | Recruiting | Tampa | Florida | 33634 | United States |
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| Charter Research - Lady Lake ( Site 1019) | Recruiting | The Villages | Florida | 32162 | United States |
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| Conquest Research LLC ( Site 1053) | Recruiting | Winter Park | Florida | 32789 | United States |
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| CenExel iResearch, LLC ( Site 1015) | Recruiting | Decatur | Georgia | 30030 | United States |
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| Alexian Brothers Medical Center-Neurosciences ( Site 1017) | Recruiting | Elk Grove Village | Illinois | 60007 | United States |
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| Boston Center for Memory ( Site 1008) | Recruiting | Newton | Massachusetts | 02459 | United States |
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| Clinical Research Professionals ( Site 1004) | Recruiting | Chesterfield | Missouri | 63005 | United States |
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| The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064) | Recruiting | Ridgewood | New Jersey | 07450 | United States |
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| The Cognitive and Research Center of NJ ( Site 1057) | Recruiting | Springfield | New Jersey | 07081 | United States |
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| CenExel- AMRI ( Site 1018) | Recruiting | Toms River | New Jersey | 08755 | United States |
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| Alzheimer Disease Research Center (ADRC) ( Site 1000) | Recruiting | Albany | New York | 12208 | United States |
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| Mid Hudson Medical Research ( Site 1050) | Recruiting | New Windsor | New York | 12553 | United States |
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| Basil Clinical ( Site 1065) | Recruiting | Queens | New York | 11413 | United States |
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| AMC Research, LLC ( Site 1006) | Recruiting | Matthews | North Carolina | 28105 | United States |
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| Insight Clinical Trials ( Site 1011) | Recruiting | Independence | Ohio | 44131 | United States |
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| Neuro-Behavioral Clinical Research ( Site 1028) | Recruiting | North Canton | Ohio | 44720 | United States |
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| Flourish Research ( Site 1048) | Recruiting | Plymouth Meeting | Pennsylvania | 19462 | United States |
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| Gadolin Research ( Site 1032) | Recruiting | Beaumont | Texas | 77702 | United States |
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| Horizon Clinical Research Center - Houston ( Site 1026) | Recruiting | Cypress | Texas | 77429 | United States |
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| Organizacion Medica de Investigacion ( Site 0401) | Recruiting | Ciudad de Buenos Aires | Buenos Aires F.D. | C1015ABO | Argentina |
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| Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0404) | Recruiting | Ciudad de Buenos Aires | Buenos Aires F.D. | C1431FWO | Argentina |
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| Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400) | Recruiting | Caba | C1428AQK | Argentina |
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| Southern Neurology ( Site 0306) | Recruiting | Kogarah | New South Wales | 2217 | Australia |
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| KARA Institute for Neurological Diseases ( Site 0302) | Recruiting | Macquarie Park | New South Wales | 2113 | Australia |
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| Austin Health ( Site 0300) | Recruiting | Ivanhoe | Victoria | 3079 | Australia |
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| HammondCare ( Site 0301) | Recruiting | Malvern | Victoria | 3144 | Australia |
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| Cliniques universitaires Saint-Luc ( Site 3001) | Recruiting | Brussels | Bruxelles-Capitale, Region de | 1200 | Belgium |
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| UZ Leuven ( Site 3000) | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| AZ Groeninge Campus Kennedylaan ( Site 3002) | Recruiting | Kortrijk | West-Vlaanderen | 8500 | Belgium |
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| Ottawa Memory Clinic ( Site 2001) | Recruiting | Ottawa | Ontario | K1Z 1G3 | Canada |
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| Sunnybrook Research Institute ( Site 2003) | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| Toronto Western Hospital ( Site 2004) | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| Clinique Mémoire de Montreal ( Site 2000) | Recruiting | Montreal | Quebec | H3G 1H9 | Canada |
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| National Center for Geriatrics and Gerontology ( Site 9002) | Recruiting | Ōbu | Aichi-ken | 474-8511 | Japan |
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| Chibaken Saiseikai Narashino Hospital ( Site 9000) | Recruiting | Narashino | Chiba | 275-8580 | Japan |
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| Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016) | Recruiting | Kawasaki | Kanagawa | 210-0852 | Japan |
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| Mie University Hospital ( Site 9011) | Recruiting | Tsu | Mie-ken | 514-8507 | Japan |
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| Katayama Medical Clinic ( Site 9005) | Recruiting | Kurashiki | Okayama-ken | 710-0813 | Japan |
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| National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004) | Recruiting | Kanzaki-gun | Saga-ken | 8420192 | Japan |
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| Tokyo Medical University Hospital ( Site 9003) | Recruiting | Shinjuku | Tokyo | 160-0023 | Japan |
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| Inage Neurology and Memory Clinic ( Site 9001) | Recruiting | Chiba | 263-0043 | Japan |
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| Kyushu University Hospital ( Site 9010) | Recruiting | Fukuoka | 812-8582 | Japan |
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| Okayama City General Medical Center Okayama City Hospital ( Site 9008) | Recruiting | Okayama | 700-8557 | Japan |
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| Brain Research Center Den Bosch B.V. ( Site 5001) | Recruiting | 's-Hertogenbosch | North Brabant | 5223 LA | Netherlands |
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| Brain Research Center. ( Site 5000) | Recruiting | Amsterdam | North Holland | 1081 GN | Netherlands |
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| Brain Research Center Zwolle ( Site 5002) | Recruiting | Zwolle | Overijssel | 8025 AZ | Netherlands |
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| National Neuroscience Institute ( Site 0101) | Recruiting | Singapore | Central Singapore | 308433 | Singapore |
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| Tan Tock Seng Hospital ( Site 0102) | Recruiting | Singapore | Central Singapore | 308433 | Singapore |
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| Hanyang University Hospital ( Site 0200) | Recruiting | Seoul | 04763 | South Korea |
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| Samsung Medical Center ( Site 0202) | Recruiting | Seoul | 06351 | South Korea |
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| Ewha Womans University Seoul Hospital ( Site 0201) | Recruiting | Seoul | 07804 | South Korea |
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| Hospital Universitari Mutua Terrassa ( Site 6004) | Recruiting | Terrassa | Barcelona | 08222 | Spain |
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| Fundació ACE ( Site 6003) | Recruiting | Barcelona | Catalonia | 08028 | Spain |
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| Hospital del Mar ( Site 6001) | Recruiting | Barcelona | 08003 | Spain |
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| Hospital Clinic i Provincial ( Site 6002) | Recruiting | Barcelona | 08036 | Spain |
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| Scottish Brain Sciences Aberdeen ( Site 8001) | Recruiting | Aberdeen | Aberdeen City | AB25 2XE | United Kingdom |
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| Scottish Brain Sciences ( Site 8000) | Recruiting | Edinburgh | Edinburgh, City of | EH12 5PJ | United Kingdom |
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| Moorgreen Hospital ( Site 8004) | Recruiting | Southampton | Hampshire | SO30 3JB | United Kingdom |
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| Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006) | Recruiting | London | London, City of | NW1 2PG | United Kingdom |
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| Warneford Hospital ( Site 8007) | Recruiting | Oxford | Oxfordshire | OX3 7JX | United Kingdom |
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| Remind UK ( Site 8003) | Recruiting | Bath | Somerset | BA1 3NG | United Kingdom |
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| Re:Cognition Health - Birmingham ( Site 8002) | Recruiting | Birmingham | B16 8LT | United Kingdom |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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