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XanaMIA-DR

CompletedPhase 1 / PHASE2

A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers

XanaMIA-DR a Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Pharmacodynamics and Safety of Xanamem® in Healthy Elderly Volunteers

Lead sponsor

Actinogen Medical

Asset

Xanamem

Listed sites

5

Recruiting sites

-

Enrollment

107

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

Age 50-80

Primary endpoints

Short-term efficacyAssessment of safety and tolerability of different Xanamem® doses by

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDACW0005
NCT IDNCT04983368

Timeline

Milestones

Study start2021-06-30actual
Study first posted2021-07-30actual
Primary completion2022-02-11actual
Study completion2022-02-11actual
Last update posted2025-01-23actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Male or female aged 50 to 80

2. Body mass index 17.5 to < 35 kg/m2, inclusive at the time of screening

3. Mini-Mental State Score of ≥ 25 points at screening

4. Must provide written informed consent

Exclusion criteria

1. Abnormalities in vital signs at screening or baseline

2. Clinically significant abnormal hematology or biochemistry values, as determined by the investigator at screening and/or baseline.

3. Previous clinically significant systemic illness or infection within the past 4 weeks prior to screening or baseline, as determined by the investigator

4. Clinically significant ECG abnormalities

5. Use of tobacco- or nicotine-containing products in the past month or unwillingness to abstain during study participation

6. Participation in another clinical study of a drug or device

7. Known allergy to the study drug (Xanamem®) or any of the excipients

8. Subjects who are likely to be unable to comply with the study schedule and/ or subjects with an inability to communicate well with the investigator

9. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies at screening

10. Subjects with a history of drug abuse or addiction in the past 5 years.

11. Evidence of alcohol abuse (defined as greater than 21 standard units per week for males and greater than 14 standard units per week for females)

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
1
Executive function / language
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Primary/protocol endpoint

Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.

Time frame:Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)

descriptive

Executive function / language

1 endpoint
Secondary/protocol endpoint

Short-term efficacy of different doses of Xanamem® on cognition

Time frame:Screening, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)

descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Assessment of safety and tolerability of different Xanamem® doses by the occurrence of Treatment-Emergent Adverse Events (TEAEs).

Time frame:10 Weeks [Baseline to Week 10 Follow-Up (4 Weeks Post Last Dose of Study Drug)]

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.