A study to assess how ALZ-801 affects laboratory tests and symptoms of Alzheimer's disease in patients who have a specific genotype (APOE4).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alzheon Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

30 Sep 2020 → 16 Jul 2025

Decision date (initial)

2024-11-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Alzheon Inc.

External identifiers

EU CT number

2024-515858-25-00

EudraCT number

2020-000986-17

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Efficacy, Safety, Therapy, Pharmacogenetic, Pharmacokinetic

To evaluate the effects of oral ALZ-801 in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the plasma biomarkers of core AD pathology and brain volumes
- Primary Plasma Biomarker Outcome: p-tau181
- Key Imaging Outcome: hippocampal volume on vMRI

Secondary objectives 9

1. Safety Objectives - To evaluate the safety and tolerability of chronic treatment with ALZ-801 in subjects with Early AD who are APOE4 carriers
2. Secondary Objectives - To evaluate the effects of oral ALZ-801 on other plasma biomarkers of core AD pathology and brain volumes - Secondary Plasma Biomarker Outcomes: Aβ40, Aβ42, and p-tau217 Secondary Imaging Biomarker Outcomes: cortical thickness and ventricular volume
3. Exploratory Fluid Biomarker Objectives - To evaluate the effects of oral ALZ-801 on other plasma and CSF biomarkers: - Plasma biomarker of astrocytic activation: glial fibrillary acidic protein (GFAP); Plasma biomarker of neurodegeneration: NfL; CSF biomarkers of core AD pathology: p-tau181, p-tau217, Aβ40, and Aβ42; CSF biomarker of synaptic toxicity: neurogranin; CSF biomarkers of neurodegeneration: total tau (t-tau) and NfL; CSF neuroinflammation markers: TREM2 (microglia) and YKL-40 (astrocytes)
4. Clinical Objectives - To evaluate the efficacy of ALZ-801 on tests of cognition and function: RAVLT, DSST, A-IADL, MMSE, and CDR-SB
5. Pharmacokinetic Objectives - To evaluate the PK of ALZ-801 and its metabolites in AD subjects
6. Pharmacokinetic Objectives - To evaluate the extended PK profile over 8 hours in 24 subjects (12 APOE4/4 homozygotes and 12 APOE3/4 heterozygotes) after 65 weeks of treatment (PK Profile Substudy)
7. Additional Exploratory Objectives - To evaluate the effect of ALZ-801 on other AD biomarkers as assays become available (Aβ oligomers, other p-tau isoforms, or other emerging AD biomarkers)
8. Additional Exploratory Objectives - To evaluate the effect of ALZ-801 on other MRI imaging measures
9. Objectives – Long-Term Extension (Years 1 and 2) - The objectives of the LTE periods of the study are to evaluate the long-term safety and efficacy of ALZ 801 over a total of 156 and 208 weeks, or 3 and 4 years, of treatment. This includes evaluation of safety parameters, fluid biomarkers, vMRI, and clinical outcomes over an additional 104 weeks of treatment in the LTE periods (52 weeks in LTE Year 1 and 52 weeks in LTE Year 2). In addition, the safety and tolerability of TID dosing in subjects who are eligible for dose escalation will be evaluated.

Conditions and MedDRA coding

Subjects with a clinical diagnosis of Alzheimer's disease who are APOE 4 carriers (APOE4/4, APOE3/4) and at the Early stage of disease, ages 50-80 years

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 33

1. 1. Be between the ages of 50 and 80 years, inclusive.
2. 2. Has a body weight ≥ 50 kg.
3. 3. Has a diagnosis of Probable AD Dementia or MCI due to AD in accordance with the National Institute on Aging-Alzheimer’s Association (NIA AA) Working Group Criteria [Albert et al, 2011; McKhann et al, 2011].
4. 4. Has a biomarker profile reflecting AD, according to the NIA-AA Research Framework [Jack et al, 2018] defined as follows: a) Positive amyloid PET scan on file prior to Screening OR b) CSF AD biomarker result using the Lumipulse (Fujirebio) assay at Screening with: i. Aβ42/Aβ40 ratio < 0.61 AND ii. p-tau > 61 ng/L OR iii. If p-tau181 concentration = 50 to 61 ng/L, ratio of p tau/Aβ42 > 0.11 OR c) CSF AD biomarker result on file within 12 months prior to Screening that is positive for Aβ42 (below the cut-off) AND p-tau (above the cut-off) OR a p tau181/Aβ42 ratio above the cut-off for that assay (amyloid AND p-tau positive) Note 1: Subjects without a prior CSF result must provide a new CSF sample at the Screening – Part 2 Visit. Note 2: Subjects with a prior positive CSF result (allowing study enrollment) must provide 2 to 3 aliquots of CSF from their prior diagnostic assessment; and the prior CSF result must be recorded.
5. 5. Be willing to undergo LP for CSF testing according to the Schedule of Assessments [Table 5].
6. 6. Has one of the following apolipoprotein E (APOE) genotypes – either APOE4/4 (homozygous) or APOE3/4 (heterozygous). Note: For subjects with a prior (historical) APOE genotype blood test, the test result must be provided and recorded in the CRF.
7. 7. Has an MMSE score at Screening of 22 to 30 inclusive (> 26 for MCI; 22 to 26 for Mild AD).
8. 8. Has a CDR Global Score at Screening of 0.5 (MCI, Mild AD) or 1 (Mild AD) and a CDR Memory Box Score of ≥ 0.5.
9. 9. Has a reliable caregiver or study partner who is willing and able to sign an informed consent form (ICF), to accompany the subject to study visits, and adhere to study requirements.
10. 10. Be willing to sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved ICF indicating that he/she understands the purpose of the study and the procedures that are required for the study, and that he/she is willing to participate in the study. Subjects are free to withdraw consent at any time. If a subject is unable or deemed not competent to sign the consent form, the subject’s legally authorized representative may sign the consent form with the subject’s assent, except where local regulations and IRB/IEC approval do not allow subjects who are unable or deemed not competent to sign the consent form, to participate in the study. Note: Subjects who participate in the PK Profile Substudy for extended PK sampling will sign an additional consent form specific for the substudy.
11. 11. Can complete the cognitive testing procedures. Corrected visual and auditory acuity must be adequate to comply with the protocol.
12. 12. Lives at home independently, in a senior living facility, or in an assisted living facility.
13. 13. Both subject and caregiver/study partner are fluent in, and able, to read the local language in which study assessments are administered at the study site.
14. 14. Subject and caregiver/study partner agree to be compliant with study procedures and appear to have a high probability of completing the study.
15. 15. Caregiver/study partner agrees not to administer any prohibited concomitant medications during the study.
16. 16. If female, must have a negative serum pregnancy test and EITHER be of non-childbearing potential, described as either: • Post-menopausal (defined as at least 12 months without any menses) prior to the Screening – Part 2 Visit, or • Documented surgically sterile (has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy with or without hysterectomy and greater than 6 weeks have passed since the surgery) OR • If subject is of child-bearing potential, must have a negative urine pregnancy test prior to dosing at baseline, use a highly effective method of contraception (with a failure rate of less than 1% per year when used consistently and correctly) for the duration of the study and for 8 weeks after the last dose of study medication. Note: Highly effective methods include surgical sterilization, intrauterine device (IUD). intrauterine hormone-releasing system (IUS), hormonal contraception associated with inhibition of ovulation (e.g., pills, patches, vaginal ring, or injections). Total abstinence is also acceptable if it is the preferred and usual lifestyle of a subject.
17. 17. Has a Screening brain MRI that is not inconsistent with the diagnosis of AD and determined to be of adequate quality. Note: This MRI will provide baseline data for MRI biomarker and safety assessments.
18. 18. If treated with an AChEI, subject must be on stable treatment for at least 12 weeks prior to the Screening – Part 2 Visit and must be able to continue on the same dose/regimen for the duration of the study. Note: Memantine is not allowed and must not be taken within 12 weeks of the Screening – Part 2 visit.
19. 19. With the exception of a diagnosis of AD and the presence of stable medical conditions is, in the opinion of the Investigator, in good general medical health based upon the results of medical history, physical examination, laboratory tests, vital signs, and ECG.
20. 20. If treated with antidepressants, mood stabilizers, or other psychotropic medications, is on a stable dose according to Table 3.
21. 21. If taking permitted, non-psychotropic medications for the treatment of non-excluded medical conditions, is on a stable dose according to Table 3.
22. Long-Term Extension Year 1 (Weeks 104-160) - 1. Complete the last visit (Week 104) of the core study.
23. 2. Be willing to sign an IRB/IEC-approved ICF indicating that he/she understands the purpose of the study and the procedures that are required for the study and that he/she is willing to participate in the study. Subjects are free to withdraw consent at any time. If a subject is unable or deemed not competent to sign the consent form, the subject’s legally authorized representative may sign the consent form with the subject’s assent, except where local regulations and IRB/IEC approval do not allow subjects who are unable or deemed not competent to sign the consent form, to participate in the study.
24. 3. Agree (subject and caregiver/study partner) to be compliant with study procedures and, in the opinion of the Investigator, have a high probability of completing the study.
25. 4. Have stable medical conditions in the opinion of the Investigator.
26. Long-Term Extension Year 2 (Weeks 156-212) - 1. Complete the last visit (Week 156) of the LTE Year 1
27. 2. Be willing to sign an IRB/IEC-approved ICF indicating that he/she understands the purpose of the study and the procedures that are required for the study and that he/she is willing to participate in the study. Subjects are free to withdraw consent at any time. If a subject is unable or deemed not competent to sign the consent form, the subject’s legally authorized representative may sign the consent form with the subject’s assent, except where local regulations and IRB/IEC approval do not allow subjects who are unable or deemed not competent to sign the consent form, to participate in the study.
28. 3. Agree (subject and caregiver/study partner) to be compliant with study procedures and, in the opinion of the Investigator, have a high probability of completing the study.
29. 4. Have stable medical conditions in the opinion of the Investigator.
30. In addition, to be eligible for dose escalation to TID dosing, the subject must: 5. Have MMSE score <22 at clinic visit between Weeks 156-196 (Visits 5E-8E).
31. 6. When the MMSE score is <22, be willing to sign the TID dosing section of the IRB/IEC-approved ICF indicating that he/she understands the TID dose escalation. Subjects are free to withdraw consent at any time. If a subject is unable or deemed not competent to sign the TID dosing section of the consent form, the subject’s legally authorized representative may sign with the subject’s assent, except where local regulations and IRB/IEC approval do not allow subjects who are unable or deemed not competent to sign the consent form, to participate in the study.
32. 7. Have tolerated the BID dose for the last 3 months.
33. 8. Deemed by the investigator to be likely to benefit from the TID dose and to complete the LTE Year 2.

Exclusion criteria 33

1. 1. Has a brain MRI at screening indicative of significant abnormality, including, but not limited to, prior hemorrhage (> 1 cm) or large infarct (> 1 cm), > 2 lacunar infarcts outside the brain stem, severe white matter changes (Fazekas grade 3), superficial hemosiderosis > 1 cm, aneurysm, vascular malformation, subdural hematoma, space-occupying lesion (e.g., abscess or brain tumor such as meningioma), or ventricular enlargement consistent with normal pressure hydrocephalus. Note: Ventricular enlargement consistent with AD atrophy (hydrocephalus ex-vacuo) is not exclusionary Note: Subjects who have > 10 microbleeds, require approval by Sponsor Medical Monitor
2. 2. Has a diagnosis of neurodegenerative disorder other than AD.
3. 3. Has a current diagnosis of Major Depressive Disorder (MDD) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition. Subjects who do not meet current criteria for MDD and who are on stable doses of antidepressants or mood stabilizers may be included in the study at the discretion of the Investigator [see Table 3].
4. 4. Has a history of suicidal behavior or has ongoing suicidal ideation.
5. 5. Has a history of seizures (excluding febrile seizures of childhood, or a single distant seizure > 10 years). Subjects with a history of one seizure, but without evidence of vascular or mixed dementia, or brain tumor on MRI, may be allowed into the study at the discretion of the Medical Monitor.
6. 6. Has a medically confirmed history of recent cerebral infarct or recent transient ischemic attack (within 1 year prior to the Screening – Part 2 Visit).
7. 7. Has a medically confirmed history of recent myocardial infarction or unstable, untreated coronary artery disease, or angina pectoris (within 1 year prior to the Screening – Part 2 Visit).
8. 8. Has a history of cancer, diagnosed and treated within the last 3 years prior to the Screening – Part 2 Visit, with the exception of the following: (a) treated basal cell carcinoma of the skin, or (b) treated in situ or Stage 1 cancers of skin (squamous cell only), colon, prostate, breast, or colon (requires approval by the Medical Monitor).
9. 9. Has a hemoglobin level < 11 g/dL in male subjects or < 10 g/dL in female subjects, or a hemoglobin level > 16 g/dL.
10. 10. Has a prothrombin time as measured by INR ≥ 1.5 and a platelet count ≤ 50 x 10^9/L.
11. 11. Has donated blood within 8 weeks prior to the Screening – Part 2 Visit.
12. 12. Has clinically relevant abnormalities in serum thyroid-stimulating hormone or calcium. If the subject is taking replacement therapy, corresponding Screening test values must be clinically acceptable.
13. 13. Has serum vitamin B12 below the lower limit of normal.
14. 14. Has any clinical chemistry laboratory value greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE; version 4.0; National Cancer Institute 2009) Grade 2, unless considered not clinically relevant by the Investigator and the Medical Monitor.
15. 15. The subject at Screening has one or more of the following: a. Alanine aminotransferase (ALT) ≥ 3 × upper limit of normal (ULN), OR b. Aspartate aminotransferase (AST) ≥ 3 × ULN, OR c. Total bilirubin (TBL) ≥ 1.5 × ULN.
16. 16. Has an estimated glomerular filtration rate < 40 ml/min per 1.73 m2 according to the Modification of Diet in Renal Disease formula [see National Institute of Diabetes and Digestive and Kidney Diseases website for formula https://www.niddk.nih.gov/health-information/professionals/clinical-tools-patient-management/kidney-disease/laboratory-evaluation/glomerular-filtration-rate-calculators/mdrd-adults-si-units].
17. 17. Has a glycosylated hemoglobin (HbA1c) > 8% (National Glycohemoglobin Standardization Program) or 64 mmol/mol (International Federation of Clinical Chemistry) at the Screening – Part 1 Visit.
18. 18. Has a history of alcohol or drug dependence or abuse within 2 years of the Screening – Part 2 Visit or tests positive for drugs of abuse (i.e., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine) at the Screening – Part 2 Visit. Note 1: If positive for opiates, the subject must be taking prescription medicines for pain and be on a stable dose of medication for more than 4 weeks prior to the Screening – Part 2 Visit. Note 2: If positive for benzodiazepines, the subject must be taking prescription medicines containing benzodiazepines and be on a permitted dose according to Table 3.
19. 19. Has a lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder.
20. 20. Has any significant medical condition (e.g., uncontrolled cardiovascular, GI, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or malignancy) that is unstable and that would either: (a) place the subject at undue risk from administration of study drug or from undergoing study procedures, or (b) interfere with the interpretation of safety or efficacy evaluations obtained in the course of the study.
21. 21. Has participated in a clinical study of any potential disease-modifying AD treatment, and received active drug within 6 months prior to the Screening – Part 2 Visit [see Table 3].
22. 22. Has participated in a clinical study and received active treatment with an anti-amyloid or anti-tau vaccine [see Table 3].
23. 23. Has received any of the treatments listed in Table 3 more recently than the indicated period before the Screening – Part 2 Visit.
24. 24. Anticipates receiving any of the treatment listed in Table 3, during the current clinical study (unless meeting criteria for exceptions to prohibition as listed in Table 3).
25. 25. Is unable to swallow ALZ-801 tablets or has a known intolerance or hypersensitivity to tramiprosate or any of the excipients contained in the ALZ-801 tablets.
26. 26. Has a history of, or currently has, any clinically significant ECG finding, or a QT interval corrected by Fridericia’s method (QTcF) of > 450 msec for males and > 470 msec for females.
27. 27. Has positive serology for the human immunodeficiency virus (HIV) or for hepatitis B or C virus.
28. Long-Term Extension Year 1 (Weeks 104-160) - 1. Withdrew from core study before completing the Week 104 visit.
29. 2. Were noncompliant (<70%) with the study medication or, in the Investigator’s or Sponsor’s opinion, with the study procedures in the core study.
30. 3. Had a clinically significant medical, surgical, laboratory, or other abnormality at the Week 104 visit of the core study that would compromise their participation in the LTE or compromise their safety in the opinion of the Investigator.
31. Long-Term Extension Year 2 (Weeks 156-212) - 1. Withdrew from LTE Year 1 before completing the Week 156 visit.
32. 2. Were noncompliant (<70%) with the study medication or, in the Investigator’s or Sponsor’s opinion, with the study procedures in the LTE Year 1.
33. 3. Had a clinically significant medical, surgical, laboratory, or other abnormality at the Week 156 visit of the LTE Year 1 that would compromise their participation in the continued LTE or compromise their safety in the opinion of the Investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Primary Plasma Biomarker Outcome: change from baseline to Week 104 in plasma biomarker of core AD pathology: p-tau181
2. Key Imaging Outcome: change from baseline to Week 104 in hippocampal volume on vMRI
3. Long-Term Extension (Year 1) - Primary Plasma Biomarker Outcome: change from study baseline to Week 156 in plasma biomarkers: p-tau181
4. Long-Term Extension (Year 1) - Key Imaging Outcome: change from study baseline to Week 156 in hippocampal volume on vMRI
5. Long-Term Extension (Year 2) - Primary Plasma Biomarker Outcome: change from study baseline to Week 208 in plasma biomarkers: p-tau181
6. Long-Term Extension (Year 2) - Key Imaging Outcome: change from baseline to Week 208 in hippocampal volume on vMRI

Secondary endpoints 51

1. Incidence and nature of TEAE, serious TEAE, and TEAE leading to withdrawal
2. Changes in laboratory parameters, vital signs, and physical examination
3. Changes in 12-lead electrocardiogram (ECG) parameters
4. MRI assessments for Amyloid-Related Imaging Abnormalities with edema (ARIA E) or microhemorrhages (ARIA-H)
5. Secondary Fluid Biomarker Outcome - Change from baseline to Week 104 in plasma biomarkers of other core AD pathologies: Aβ40, Aβ42, and p-tau217
6. Secondary Imaging Biomarker Outcome - Change from baseline to Week 104 in cortical thickness and ventricular volume
7. Exploratory Fluid Biomarker Outcomes - Change from baseline to Week 104 in biomarker of plasma GFAP
8. Change from baseline to Week 104 in plasma NfL
9. Change from baseline to Week 104 in CSF p-tau181, p-tau217, Aβ40, and Aβ42
10. Change from baseline to Week 104 in CSF neurogranin
11. Change from baseline to Week 104 in CSF t-tau and NfL
12. Change from baseline to Week 104 in CSF TREM2 and YKL-40
13. Clinical Outcomes - Change from baseline to Week 104 in RAVLT, DSST, A-IADL MMSE, CDR-SB
14. Pharmacokinetic and Pharmacodynamic Outcomes - Plasma and CSF levels of ALZ-801, tramiprosate, and its metabolite before and after first dose, at steady state, and at later time points in the study. PK non-compartmental analysis will be performed using Phoenix WinNonlin (version 7.0 or later).
15. Correlation of PK levels to biomarker outcomes.
16. Correlation of PK levels to efficacy and safety parameters.
17. Extended PK profile over 8 hours on Week 65 will be evaluated in approximately 24 subjects (approximately 12 APOE4/4 homozygotes and 12 APOE3/4 heterozygotes) who have consented to participate in the PK Profile Substudy.
18. Additional Fluid and Imaging Biomarker Outcomes - Change from baseline to Weeks 6, 13, 26, 52, and 78 for plasma biomarkers
19. Change from baseline to Week 52 in hippocampal volume, cortical thickness, and ventricular volume
20. Change from baseline to Week 52 and 104 in other exploratory MRI imaging outcomes (to be described in the SAP)
21. Change from baseline to Week 52 for CSF biomarkers
22. Additional Clinical Outcomes - Change from baseline to Weeks 13, 26, 52, and 78 for RAVLT and DSST
23. Change from baseline to Weeks 13, 26, 39, 52, 65, 78, and 91 for MMSE
24. Change from baseline to Week 52 for A-IADL and CDR-SB
25. Long-Term Extension (Year 1) - Safety Outcomes - Safety and tolerability over 156 weeks of study and over 52 weeks of the LTE Year 1 as listed in Section 2.2.2
26. Secondary Fluid Biomarker Outcome - Change from study baseline to Week 156 in plasma biomarkers: p-tau217, Aβ40, and Aβ42
27. Secondary Imaging Biomarker Outcome - Change from study baseline to Week 130 in hippocampal volume
28. Change from baseline to Weeks 130 and 156 on cortical thickness, whole brain volume and ventricular volume on vMRI
29. Exploratory Fluid Biomarkers Outcomes - Change from baseline to Week 156 in plasma GFAP
30. Change from baseline to Week 156 in plasma NfL
31. Change from baseline to Week 156 in CSF p-tau181, p-tau217, Aβ40, and Aβ42
32. Change from baseline to Week 156 in CSF neurogranin
33. Change from baseline to Week 156 in CSF t-tau and NfL
34. Change from baseline to Week 156 in CSF sTREM2 and YKL-40
35. Clinical Outcomes - Change from baseline to Weeks 130 and 156 in the clinical outcomes: RAVLT, DSST, MMSE, A-IADL, and CDR-SB
36. Pharmacokinetic Outcomes - PK assessments for ALZ-801 and its metabolites as in Section 2.2.7
37. Additional Fluid and Imaging Biomarker Outcomes - Change from baseline to Week 130 in plasma biomarkers: GFAP, NfL, p-tau181, p-tau217, Aβ40, and Aβ42
38. Change from baseline to Weeks 130 and 156 in other exploratory MRI imaging outcomes (as described in the SAP)
39. Change from LTE baseline (Week 104) to Weeks 130 and 156 in MRI diffusion tensor imaging (DTI)
40. Long-Term Extension (Year 2) - Safety Outcomes - Safety and tolerability over 104 weeks of the LTE-assessments (and over 208 weeks in the overall study) as listed in Section 2.2.2
41. Secondary Fluid Biomarker Outcome - Change from baseline to Week 208 in plasma biomarkers: p-tau217, Aβ40, and Aβ42
42. Secondary Imaging Biomarker Outcome - Change from baseline to Week 182 in hippocampal volume
43. Change from baseline to Weeks 182 and 208 in cortical thickness, whole brain volume and ventricular volume on vMRI
44. Exploratory Fluid Biomarkers Outcomes - Change from baseline to Week 208 in plasma GFAP
45. Change from baseline to Week 208 in plasma NfL
46. Clinical Outcomes - Change from baseline to Weeks 168, 182, 196, and 208 in the clinical outcomes: RAVLT, DSST, MMSE, A-IADL, and CDR-SB
47. Change from baseline on the NPI: change from the first clinic assessment of the NPI to assessments at all later visits
48. Pharmacokinetic Outcomes - PK assessments for ALZ-801 and its metabolites as in Section 2.2.7
49. Additional Fluid and Imaging Biomarker Outcomes - Change from baseline to Weeks 168, 182, 196 in plasma biomarkers: GFAP, NfL, p-tau181, p-tau217, Aβ40, and Aβ42
50. Change from baseline to Weeks 182 and 208 in other exploratory MRI imaging outcomes (as described in the SAP)
51. Change from LTE Year 1 baseline (Week 104) to Weeks 130, 156, 182, and 208 in MRI DTI measures.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alzheon Inc.

Sponsor organisation

Alzheon Inc.

Address

111 Speen Street Suite 306

City

Framingham

Postcode

01701-2090

Country

United States

Scientific contact point

Organisation

Alzheon Inc.

Contact name

Alzheon CT Information Desk

Public contact point

Organisation

Alzheon Inc.

Contact name

Alzheon CT Information Desk

Third parties 5

Locations

2 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications