Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
12. december 2014 opdateret af: Pfizer
A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease
The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
53
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Osaka, Japan, 530-8480
- Tazuke Kofukai Medical Research Institute Kitano Hospital
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Aichi
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Nagoya, Aichi, Japan, 451-8511
- Meitetsu Hospital
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Ibaraki
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Kasama, Ibaraki, Japan, 309-1793
- Ibaraki Prefectural Central Hospital
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Kanagawa
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Atsugi, Kanagawa, Japan, 243-8551
- Shonan Atsugi Hospital
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Sagamihara-shi, Kanagawa, Japan, 252-0380
- Kitasato University East Hospital
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Nagano
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Suwa, Nagano, Japan, 392-8510
- Suwa Red Cross Hospital
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Osaka
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Takatsuki, Osaka, Japan, 569-8686
- Osaka Medical College Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Koto-ku, Tokyo, Japan, 136-0075
- Juntendo Tokyo Koto Geriatric Medical Center
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Minato-ku, Tokyo, Japan, 105-8471
- The Tokyo Jikei University School of Medicine
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Setagaya-ku, Tokyo, Japan, 158-8531
- Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
52 år til 87 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
- Screening brain MRI scan is consistent with the diagnosis of AD.
- MMSE score 10 and above.
Exclusion Criteria:
- Significant neurological diseases other than AD.
- Brain MRI evidence of vasogenic edema during the preceding studies.
- Clinically significant illness.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ACC-001 (3 micrograms) + QS-21
Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
|
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
|
|
Eksperimentel: ACC-001 (10 micrograms) + QS-21
Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
|
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
|
|
Eksperimentel: ACC-001 (30 micrograms) + QS-21
Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
|
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Treatment Emergent Adverse Events (AEs) by Severity
Tidsramme: Baseline up to 24 months
|
Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
|
Baseline up to 24 months
|
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Antal deltagere med hjerneabnormiteter i data om magnetisk resonansbilleddannelse (MRI).
Tidsramme: Baseline op til 24 måneder
|
Antal deltagere med hjerneabnormiteter i MR-data, der enten er konsistente eller ikke i overensstemmelse med AD, som bestemt af radiologer.
|
Baseline op til 24 måneder
|
|
Number of Participants With Abnormalities in Neurological Examination
Tidsramme: Baseline of the preceding studies through 24 months of this study
|
Number of participants with abnormalities in neurological examinations as determined by the investigators.
Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.
|
Baseline of the preceding studies through 24 months of this study
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits
Tidsramme: Baseline of preceding studies to month 24 of this study (Week 210)
|
Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study
|
Baseline of preceding studies to month 24 of this study (Week 210)
|
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Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits
Tidsramme: Baseline of preceding studies to month 24 of this study (Week 210)
|
Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study
|
Baseline of preceding studies to month 24 of this study (Week 210)
|
|
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.
Tidsramme: Baseline up to 24 Months
|
The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility.
For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment.
The total score ranges from 0 (no impairment) to 70 (worst impairment).
|
Baseline up to 24 Months
|
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The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.
Tidsramme: Baseline up to 24 Months
|
The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living.
A total score is obtained by adding the rating for each question and converting this total score out of 100.
Higher scores represent less disability in ADL while lower scores indicate more dysfunction.
|
Baseline up to 24 Months
|
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The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.
Tidsramme: Baseline up to 24 Months
|
The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function.
The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test.
The NTB z-score is used for analysis.
The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study.
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Baseline up to 24 Months
|
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The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.
Tidsramme: Baseline up to 24 Months
|
The MMSE is a brief, structured examination of cognitive function.
It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.
|
Baseline up to 24 Months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2010
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
21. oktober 2010
Først indsendt, der opfyldte QC-kriterier
9. november 2010
Først opslået (Skøn)
11. november 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B2571001
- 3134K1-2207 (Anden identifikator: Alias Study Number)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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