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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002873-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Kyowa Hakko Kirin Pharma, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK6640 | Experimental | KHK6640 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK6640 | Drug | Single ascending dose and multiple ascending doses administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs, laboratory parameters (hematology, chemistry, and urinalysis), vital signs, 12-lead electrocardiograms, physical and neurological examinations, and brain MRI | Up to 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent, De Pintelaan 185 | Ghent | 9000 | Belgium | |||
| Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B, |
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| Matching Placebo |
| Drug |
Single ascending dose and multiple ascending doses administration |
|
| Turku |
| FI-20520 |
| Finland |
| Department of Neurology and Alzheimer Center, VU University Medical Center | Amsterdam | 1081 GM | Netherlands |
| University Medical Centre Groningen (UMCG), Alzheimer Research Centre | Groningen | 9700 RB | Netherlands |
| Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 , | Belgrade | 11 000 | Serbia |
| Military Medical Academy, Crnotravska 17, | Belgrade | 11 000 | Serbia |
| Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33, | Malmö | SE-205 02 | Sweden |
| Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6 | Mölndal | SE-43141 | Sweden |
| Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit | Stockholm | SE-141 86 | Sweden |
| 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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