Mild Cognitive ImpairmentPhase 2NCT04191486
Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD
A Phase 2 study testing T-817MA in people with Mild Cognitive Impairment, run by FUJIFILM Toyama Chemical Co., Ltd. at 37 sites in 7 countries.
Trial summary
Primary objective is to evaluate the neuroprotective effect of T-817MA on Tau protein phosphorylated at threonine 181 (p-tau 181) in cerebrospinal fluid (CSF) compared with placebo in patients with a diagnosis of MCI due to AD or mild AD. Secondary objectives are: 1. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- T-817MA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 24 Dec 2019to 20 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female of non-childbearing potential or male, ages 50 to 80 years (inclusive)
- MCI due to AD or mild AD per NIA-AA diagnostic criteria (Jack et al., 2018), with MMSE 24 to 30 (inclusive)
- CSF results at Screening consistent with the presence of Aß and p-tau181 abnormality (≤1000 pg/ml for Aß, ≥19 pg/ml for p-tau181).
- Taking stable dose of AChE Inhibitor (donepezil, galantamine or rivastigmine) at least for 3 months prior to randomization, or not taking any AChE Inhibitors.
Who cannot join
- MRI of the brain within the previous 2 years that showed pathology that would be inconsistent with a diagnosis of AD
- Taking memantine
- Any contraindications to lumbar puncture
- Any contraindications to MRI
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
Germany9 sites
Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt
Frankfurt
Klinik für Neurologie Universitätsklinikum Schleswig-Holstein
Kiel
Klinik und Poliklinik für Neurologie Universitätsklinikum Leipzig
Leipzig
Universitätsklinikum Magdeburg Institut für Kognitive Neurologie und Demenzforschung
Magdeburg
Institut für Studien zur Psychischen Gesundheit (ISPG)
Mannheim
Technische Universität München
München
Universitätsklinikum Münster Klinik für Allgemeine Neurologie
Münster
Universitätsmedizin Rostock Zentrum für Nervenheilkunde Klinik für Psychosomatik und Psychotherapeutische Medizin
Rostock
Universitätsklinikum Ulm Studienzentrum Klinik für Neurologie
Ulm
Spain8 sites
Hospital General Universitari d' Elx
Alicante
Fundació ACE
Barcelona
Àrea Gestió Documentació Assaigs Clínics-AGDAC Hospital Santa Creu i Sant Pau
Barcelona
Hospital Clínico Universitario Virgen de La Arrixaca
El Palmar
CAE Oroitu
Getxo
Complejo Asistencial Universitario de Salamanca
Salamanca
Hospital Victoria Eugenia - Cruz Roja
Seville
Hospital Viamed Montecanal
Zaragoza
Czechia5 sites
FNUSA - Mezinarodni centrum klinickeho vyzkumu
Brno
FNHK - Neurologicka klinika
Hradec Králové
A-shine, s.r.o.
Pilsen
CLINTRIAL, s.r.o.
Prague
VESTRACLINICS, s.r.o.
Rychnov
United Kingdom5 sites
University of Bath
Bath
Southmead Hospital North Bristol NHS Trust
Bristol
Glasgow memory Clinic
Glasgow
Imperial College Healthcare NHS Trust
London
Memory Assessment & Research Centre
Southampton
Hungary4 sites
Debreceni Egyetem KK, Pszichiátriai Klinika
Budapest
Jávorszky Ödön Városi Kórház, Gyógyszertár
Debrecen
Semmelweis Egyetem, Pszichiátriai és Pszichoterápiás Klinika
Győr
Semmelweis Egyetem Neurológiai Klinika Gyógyszertára, C földszint
Vác
Netherlands4 sites
Brain Research Center Den Bosch
's-Hertogenbosch
Brain Research Center
Amsterdam
Amphia ziekenhuis
Breda
Isala ziekenhuis
Zwolle
Ireland2 sites
St. Vincent's University Hospital
Dublin
Tallaght University Hospital.
Dublin
About this study
Official title: A Phase 2 Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
Primary objective is to evaluate the neuroprotective effect of T-817MA on Tau protein phosphorylated at threonine 181 (p-tau 181) in cerebrospinal fluid (CSF) compared with placebo in patients with a diagnosis of MCI due to AD or mild AD.
Secondary objectives are:
Read more
- To evaluate in patients on T-817MA and placebo:
- cognitive function measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and working memory and attention domain as measured by the Cognitive Functional Composite (CFC).
- AD-related biomarkers in CSF and plasma
- imaging analysis using volumetric magnetic resonance imaging (vMRI)
- alpha/theta ratio of the electroencephalogram (EEG)
- To evaluate the safety of T-817MA by clinical laboratory tests and adverse events (AEs).
- To evaluate the pharmacokinetics of T-817MA
- Conditions
- Mild Cognitive Impairment
- Being tested
- T-817MA, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-817MADrug
224mg T-817MA orally once daily for first 4 weeks, and then 448mg T-817MA orally once daily for the following weeks.
PlaceboDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| T-817MA (448 mg) | Experimental | Not described Receives: Drug: T-817MA |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the CSF p-tau181 from Baseline to Week 78
Measured: Baseline to Week 78
Secondary outcomes (19)
The change in the CSF p-tau181 from Baseline to Week 52
Measured: Baseline to Week 52
The change in the CSF p-tau217 from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the CSF total tau from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the CSF Aβ1-42 from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the CSF Aβ1-40 from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the CSF neurofilament light (NFL) from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the CSF neurogranin from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the CSF YKL-40 from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the CSF Aβ1-42/Aβ1-40 ratio from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the plasma Aβ1-42 from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the plasma Aβ1-40 from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in the plasma NFL from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in cognitive function assessed by CDR-sb and working memory and attention domain as measured by the CFC from Baseline to Weeks 28, 52 and 78
Measured: Baseline to Weeks 28, 52 and 78
The change in brain volume (total brain volume (TBV), ventricular volume and hippocampal volume) and cortical thickness measured by vMRI from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
The change in alpha/theta ratio measured by the EEG from Baseline to Weeks 52 and 78
Measured: Baseline to Weeks 52 and 78
Safety as assessed by the occurrence of AEs, clinical laboratory tests, vital signs, physical examinations, ECGs
Measured: Screening to Week 82
Population PK analysis of T-817MA with assessment of maximum plasma concentration (Cmax)
Measured: Weeks 16, 28, 40, and 65
Population PK analysis of T-817MA with assessment of minimum plasma concentration (Cmin)
Measured: Weeks 16, 28, 40, and 65
Population PK analysis of T-817MA with assessment of total daily exposure (AUC0-24h)
Measured: Weeks 16, 28, 40, and 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start24 Dec 2019
- Primary completion22 Feb 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Scheltens, MD, PhD, Study director, VUmc Alzheimer Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191486
- Sponsor's protocol ID
- T817MAEU201
- Other IDs
- 2018-003567-66, 2018
- Status last verified
- Feb 2023
- First submitted
- 26 Nov 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Details for sharing data have not been decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04191486
- Acronym / sponsor ID
- T817MAEU201
- Conditions
- Mild Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective is to evaluate the neuroprotective effect of T-817MA on Tau protein phosphorylated at threonine 181 (p-tau 181) in cerebrospinal fluid (CSF) compared with placebo in patients with a diagnosis of MCI due to AD or mild AD.
Secondary objectives are:
- To evaluate in patients on T-817MA and placebo:
- cognitive function measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and working memory and attention domain as measured by the Cognitive Functional Composite (CFC).
- AD-related biomarkers in CSF and plasma
- imaging analysis using volumetric magnetic resonance imaging (vMRI)
- alpha/theta ratio of the electroencephalogram (EEG)
- To evaluate the safety of T-817MA by clinical laboratory tests and adverse events (AEs).
- To evaluate the pharmacokinetics of T-817MA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-817MA (448 mg) | Experimental | Drug: T-817MA |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female of non-childbearing potential or male, ages 50 to 80 years (inclusive)
- MCI due to AD or mild AD per NIA-AA diagnostic criteria (Jack et al., 2018), with MMSE 24 to 30 (inclusive)
- CSF results at Screening consistent with the presence of Aß and p-tau181 abnormality (≤1000 pg/ml for Aß, ≥19 pg/ml for p-tau181).
- Taking stable dose of AChE Inhibitor (donepezil, galantamine or rivastigmine) at least for 3 months prior to randomization, or not taking any AChE Inhibitors.
Key exclusion criteria (4 listed)
- MRI of the brain within the previous 2 years that showed pathology that would be inconsistent with a diagnosis of AD
- Taking memantine
- Any contraindications to lumbar puncture
- Any contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-817MA224mg T-817MA orally once daily for first 4 weeks, and then 448mg T-817MA orally once daily for the following weeks. | Drug | T-817MA (448 mg) |
| PlaceboPlacebo once daily | Drug | Placebo |
Primary outcome
The change in the CSF p-tau181 from Baseline to Week 78
Time frame: Baseline to Week 78
19 secondary outcomes
The change in the CSF p-tau181 from Baseline to Week 52
Time frame: Baseline to Week 52
The change in the CSF p-tau217 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF total tau from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF Aβ1-42 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF Aβ1-40 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF neurofilament light (NFL) from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF neurogranin from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF YKL-40 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF Aβ1-42/Aβ1-40 ratio from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the plasma Aβ1-42 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the plasma Aβ1-40 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the plasma NFL from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in cognitive function assessed by CDR-sb and working memory and attention domain as measured by the CFC from Baseline to Weeks 28, 52 and 78
Time frame: Baseline to Weeks 28, 52 and 78
The change in brain volume (total brain volume (TBV), ventricular volume and hippocampal volume) and cortical thickness measured by vMRI from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in alpha/theta ratio measured by the EEG from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
Safety as assessed by the occurrence of AEs, clinical laboratory tests, vital signs, physical examinations, ECGs
Time frame: Screening to Week 82
Population PK analysis of T-817MA with assessment of maximum plasma concentration (Cmax)
Time frame: Weeks 16, 28, 40, and 65
Population PK analysis of T-817MA with assessment of minimum plasma concentration (Cmin)
Time frame: Weeks 16, 28, 40, and 65
Population PK analysis of T-817MA with assessment of total daily exposure (AUC0-24h)
Time frame: Weeks 16, 28, 40, and 65
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided. Details for sharing data have not been decided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Scheltens, MD, PhD study director
VUmc Alzheimer Centrum
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T-817MA in people with Mild Cognitive Impairment, run by FUJIFILM Toyama Chemical Co., Ltd. at 37 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany, Spain, Czechia, United Kingdom, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the CSF p-tau181 from Baseline to Week 78 (time frame: Baseline to Week 78). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.