CompletedPhase 1/2

Study of LM11A-31-BHS in Mild-moderate AD Patients

Austria, Czechia, Germany242 participantsStarted 2017-02-15

Plain-language summary

The purpose of this study is to determine the safety of 2 doses of LM11A-31-BHS in 180 patients with Alzheimer's Disease versus placebo and to access biomarker and clinical exploratory endpoints of LM11A-31-BHS

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and women (non-childbearing potential) with a diagnosis of Alzheimer's disease according to McKhann (2011) criteria
. Age 50-85 years (50-80 in Czech Republic)

Exclusion criteria

. CSF AD specific biomarker profile; positive, defined as CSF Aβ42 \< 550 ng l-1 or an Aβ 40/42 ratio \< 0.89
. Mild to moderate stage of Alzheimer's disease according to MMSE ≥ 18 and ≤ 26
. Absence of major depressive disease according to GDS of \< 5
. Modified Hachinski Ischemic Scale ≤ 4
. Formal education for eight or more years
. Previous decline in cognition for more than six months as documented in patient medical records
0. A caregiver available and living in the same household or interacting with the patient a sufficient time each week (in Czech Republic: providing personal care for the patient during at least 10 hours per week ) and available if necessary to assure administration of drug
1. Patients living at home or nursing home setting without continuous nursing care

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of AEs/SAEs within the 26-week study period

Timeframe: 26 weeks

Trial details

NCT IDNCT03069014

SponsorPharmatrophiX Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-08

View on ClinicalTrials.gov More Mild to Moderate Alzheimer's Disease trials