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Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

2012年12月21日 更新者：Pfizer

A 52-Week, Two-Period, Multicenter, Randomized, Double-Blind, Donepezil-Referenced, Placebo-Controlled, Efficacy And Safety Study Of 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.

研究の種類

介入

入学 (実際)

526

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85004
        • Pfizer Investigational Site
      • Phoenix、Arizona、アメリカ、85050
        • Pfizer Investigational Site
    • California
      • Costa Mesa、California、アメリカ、92626
        • Pfizer Investigational Site
      • Fresno、California、アメリカ、93720
        • Pfizer Investigational Site
      • Garden Grove、California、アメリカ、92845
        • Pfizer Investigational Site
      • Long Beach、California、アメリカ、90806
        • Pfizer Investigational Site
      • Oxnard、California、アメリカ、93030
        • Pfizer Investigational Site
    • Colorado
      • Denver、Colorado、アメリカ、80218
        • Pfizer Investigational Site
      • Denver、Colorado、アメリカ、80239
        • Pfizer Investigational Site
    • Florida
      • Brooksville、Florida、アメリカ、34601
        • Pfizer Investigational Site
      • Hallandale Beach、Florida、アメリカ、33009
        • Pfizer Investigational Site
      • Miami、Florida、アメリカ、33180
        • Pfizer Investigational Site
      • Naples、Florida、アメリカ、34102
        • Pfizer Investigational Site
      • Plantation、Florida、アメリカ、33317
        • Pfizer Investigational Site
      • St. Petersburg、Florida、アメリカ、33709
        • Pfizer Investigational Site
      • St. Petersburg、Florida、アメリカ、33702
        • Pfizer Investigational Site
      • Sunrise、Florida、アメリカ、33351
        • Pfizer Investigational Site
      • Tampa、Florida、アメリカ、33613
        • Pfizer Investigational Site
      • West Palm Beach、Florida、アメリカ、33407
        • Pfizer Investigational Site
      • aTLANTIS、Florida、アメリカ、33462
        • Pfizer Investigational Site
    • Georgia
      • Atlanta、Georgia、アメリカ、30308
        • Pfizer Investigational Site
    • Illinois
      • Elk Grove Village、Illinois、アメリカ、60007
        • Pfizer Investigational Site
      • Park Ridge、Illinois、アメリカ、60068
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis、Missouri、アメリカ、63110
        • Pfizer Investigational Site
      • Saint Louis、Missouri、アメリカ、63104
        • Pfizer Investigational Site
    • New York
      • Cedarhurst、New York、アメリカ、11516
        • Pfizer Investigational Site
      • Staten Island、New York、アメリカ、10312
        • Pfizer Investigational Site
    • Ohio
      • Toledo、Ohio、アメリカ、43623
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73103
        • Pfizer Investigational Site
      • Oklahoma City、Oklahoma、アメリカ、73112
        • Pfizer Investigational Site
      • Oklahoma City、Oklahoma、アメリカ、73116
        • Pfizer Investigational Site
      • Tulsa、Oklahoma、アメリカ、74104
        • Pfizer Investigational Site
    • Oregon
      • Portland、Oregon、アメリカ、97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown、Pennsylvania、アメリカ、18104
        • Pfizer Investigational Site
    • Tennessee
      • Franklin、Tennessee、アメリカ、37067
        • Pfizer Investigational Site
    • Vermont
      • Bennington、Vermont、アメリカ、05201
        • Pfizer Investigational Site
    • Wisconsin
      • Middleton、Wisconsin、アメリカ、53562
        • Pfizer Investigational Site
  • アルゼンチン
      • Ciudad de Buenos Aires、アルゼンチン、1022
        • Pfizer Investigational Site
      • Ciudad de Buenos Aires、アルゼンチン、C1425BWO
        • Pfizer Investigational Site
    • Buenos Aires
      • C.a.b.a.、Buenos Aires、アルゼンチン、C1126AAB
        • Pfizer Investigational Site
      • Caba、Buenos Aires、アルゼンチン、1022
        • Pfizer Investigational Site
  • コロンビア
      • Valle del Cauca、コロンビア
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota、Cundinamarca、コロンビア
        • Pfizer Investigational Site
    • Risaralda
      • Pereira、Risaralda、コロンビア
        • Pfizer Investigational Site
    • Santander
      • Bucamaranga、Santander、コロンビア
        • Pfizer Investigational Site
    • Valle
      • Cali、Valle、コロンビア
        • Pfizer Investigational Site
  • チリ
      • Santiago、チリ、7530193
        • Pfizer Investigational Site
      • Santiago、チリ、7630000
        • Pfizer Investigational Site
      • Santiago、チリ、8330838
        • Pfizer Investigational Site
      • Santiago、チリ、7500922
        • Pfizer Investigational Site
      • Vina del Mar、チリ、2520997
        • Pfizer Investigational Site
  • ニュージーランド
      • Auckland、ニュージーランド、0622
        • Pfizer Investigational Site
      • Hamilton、ニュージーランド、3240
        • Pfizer Investigational Site
  • ポーランド
      • Krakow、ポーランド、31-531
        • Pfizer Investigational Site
      • Poznan、ポーランド、61-289
        • Pfizer Investigational Site
      • Wroclaw、ポーランド、50-088
        • Pfizer Investigational Site
  • メキシコ
      • Aguascalientes、メキシコ、20127
        • Pfizer Investigational Site
    • Coahuila
      • Saltillo、Coahuila、メキシコ、25000
        • Pfizer Investigational Site
  • ルーマニア
      • Bucuresti、ルーマニア、010825
        • Pfizer Investigational Site
      • Bucuresti、ルーマニア、041914
        • Pfizer Investigational Site
      • Bucuresti、ルーマニア、050098
        • Pfizer Investigational Site
      • Bucuresti、ルーマニア、011241
        • Pfizer Investigational Site
    • Dolj
      • Craiova、Dolj、ルーマニア、200317
        • Pfizer Investigational Site
    • Timis
      • Timisoara、Timis、ルーマニア、300736
        • Pfizer Investigational Site
  • ロシア連邦
      • Kazan、ロシア連邦、420101
        • Pfizer Investigational Site
      • Moscow、ロシア連邦、115522
        • Pfizer Investigational Site
      • Moscow、ロシア連邦、123182
        • Pfizer Investigational Site
      • Novosibirsk、ロシア連邦、630054
        • Pfizer Investigational Site
      • Saint-Petersburg、ロシア連邦、197022
        • Pfizer Investigational Site
      • Saint-Petersburg、ロシア連邦、190005
        • Pfizer Investigational Site
      • Saint-Petersburg、ロシア連邦、192019
        • Pfizer Investigational Site
      • Saint-Petersburg、ロシア連邦、194044
        • Pfizer Investigational Site
      • Saint-Petersburg、ロシア連邦、198103
        • Pfizer Investigational Site
      • Smolensk、ロシア連邦、214018
        • Pfizer Investigational Site
      • Yaroslavl、ロシア連邦、150030
        • Pfizer Investigational Site
    • Gatchina district, Leningrad region
      • Nikolskoe village、Gatchina district, Leningrad region、ロシア連邦、188357
        • Pfizer Investigational Site
  • 南アフリカ
      • Cape Town、南アフリカ、7530
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein、Free State、南アフリカ、9301
        • Pfizer Investigational Site
    • Gauteng
      • Johannesburg、Gauteng、南アフリカ、2196
        • Pfizer Investigational Site
      • Pretoria、Gauteng、南アフリカ、0041
        • Pfizer Investigational Site
    • Western Cape
      • Bellville、Western Cape、南アフリカ、7530
        • Pfizer Investigational Site
  • 大韓民国
      • Seoul、大韓民国、138-736
        • Pfizer Investigational Site
    • Gyeonggi-do
      • Seongnam-si、Gyeonggi-do、大韓民国、463-707
        • Pfizer Investigational Site
  • 日本
      • Chiba、日本
        • Pfizer Investigational Site
      • Fukuoka、日本
        • Pfizer Investigational Site
      • Hiroshima、日本
        • Pfizer Investigational Site
      • Kanagawa、日本
        • Pfizer Investigational Site
      • Kumamoto、日本
        • Pfizer Investigational Site
      • Kyoto、日本
        • Pfizer Investigational Site
      • Nagano、日本
        • Pfizer Investigational Site
      • Nagasaki、日本
        • Pfizer Investigational Site
      • Shizuoka、日本
        • Pfizer Investigational Site
    • Tokyo
      • Hachioji、Tokyo、日本
        • Pfizer Investigational Site
  • 香港
      • Hong Kong、香港
        • Pfizer Investigational Site
    • Hong Kong SAR, China
      • Shatin, N.T.、Hong Kong SAR, China、香港
        • Pfizer Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
  • Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
  • Rosen Modified Hachinski Ischemic score < or equal to 4 at screening.

Exclusion Criteria:

  • Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
  • Current major depressive disorder or other current major psychiatric disorder.
  • History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
  • Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：1
プラセボ
薬：Placebo
Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.
実験的：2
SAM-531 1.5 mg
薬：SAM-531 1.5 mg
Capsules SAM-531 1.5 mg, once a day during 52 weeks.
実験的：3
SAM-531 3.0 mg
薬：SAM-531 3.0 mg
Capsules SAM-531 3.0 mg, once a day during 52 weeks.
実験的：4
SAM-531 5.0 mg
薬：SAM-531 5.0 mg
Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.
アクティブコンパレータ：5
Donepezil
薬：Donepezil
Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24
時間枠：Baseline, Week 24
14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.
Baseline, Week 24

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24
時間枠：Baseline, Week 24
Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant's actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of "Not Applicable" was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL.
Baseline, Week 24
Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24
時間枠：Baseline, Week 24
Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 [occasionally] to 4 [very frequently] * symptom severity (1 [mild] to 3 [severe]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances
Baseline, Week 24
Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24
時間枠：Baseline, Week 24
Caregiver and participant interview-based tool to rate the overall impression of participant's clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.
Baseline, Week 24
Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24
時間枠：Baseline, Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.
Baseline, Week 24
Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24
時間枠：Baseline, Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24
時間枠：Baseline, Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24
時間枠：Baseline, Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.
Baseline, Week 24
Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24
時間枠：Baseline, Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.
Baseline, Week 24
Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24
時間枠：Baseline, Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.
Baseline, Week 24
Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24
時間枠：Baseline, Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB SWM Strategy at Week 24
時間枠：Baseline, Week 24
CANTAB-SWM assessed participant's ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24
時間枠：Baseline, Week 24
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB PRM-Percentage Correct at Week 24
時間枠：Baseline, Week 24
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24
時間枠：Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24
時間枠：Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24
時間枠：Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Simple Movement Time at Week 24
時間枠：Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24
時間枠：Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Baseline, Week 24
Percentage of Participants Who Were Responders at Week 24
時間枠：Week 24
Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.
Week 24

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年5月1日

一次修了 (実際)

2011年5月1日

研究の完了 (実際)

2011年5月1日

試験登録日

最初に提出

2009年5月7日

QC基準を満たした最初の提出物

2009年5月7日

最初の投稿 (見積もり)

2009年5月8日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年1月31日

QC基準を満たした最後の更新が送信されました

2012年12月21日

最終確認日

2012年12月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 3193A1-2005
  • B1961007

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

アルツハイマー病の臨床試験

  • Adelphi Values LLC
    Blueprint Medicines Corporation
    完了
    全身性肥満細胞症の患者報告アウトカムアンケート
    肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されました
    アメリカ

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