Alzheimer's antibody put to the test in india

NCT ID NCT07838155

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

Researchers are studying how well Indian patients with early Alzheimer's disease tolerate donanemab, an intravenous antibody that targets amyloid plaques in the brain. About 50 participants with mild cognitive impairment or mild dementia due to Alzheimer's will receive regular infusions over roughly 84 weeks. The study tracks brain imaging abnormalities, infusion reactions, memory test scores, and blood markers of Alzheimer's pathology.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
donanemab, an antibody given by intravenous infusion that targets amyloid plaques in the brain
What this could lead to
If donanemab proves tolerable in this population, it could offer Indian patients with early Alzheimer's a treatment option that targets the disease's underlying amyloid buildup.
What could go wrong
This is an open-label, single-arm study with no placebo comparison, so it cannot prove the drug works. Donanemab carries a known risk of brain swelling or bleeding, called ARIA, which requires monitoring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Gradual and progressive change in memory function reported by the participant or informant for greater than or equal to (≥) 6 months. * Clinical diagnosis of mild cognitive impairment due to Alzheimer's Disease (AD) or mild Alzheimer's dementia. * Evidence of amyloid pathology confirmed by plasma phosphorylated tau217 (P-tau217) levels. * A Mini Mental State Examination (MMSE) score of 20 to 28 (inclusive). * Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant, and will accompany the participant to study visits or be available by telephone at designated times. Exclusion Criteria: * Have significant neurological disease affecting the central nervous system other than AD. * Have a condition that in the investigator's opinion could interfere with the analyses of this study. * Have a life expectancy of less than 24 months. * Have a presence or history of malignant neoplasms within the past 5 years. * Are actively suicidal. * Have a diagnosis of alcohol or drug use disorder, except tobacco use disorder. * Have a history of clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity. * Have previously received or are currently receiving treatment with a passive antiamyloid immunotherapy. * Have received active immunization against amyloid-beta (Aβ) in any other study. * Have known allergies to donanemab, related compounds, or any components of the formulation. * Have any clinically important abnormality at screening. * Screening magnetic resonance imaging (MRI) that shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study. * Have an MRI demonstrating presence of amyloid-related imaging abnormalities that show cerebral edema (ARIA-E), greater than (\>) 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage, or severe white matter disease. * Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or a cardiac pacemaker. * Poor venous access. * Alanine aminotransferase (ALT) ≥2.5× upper limit of normal (ULN) of the performing laboratory, aspartate aminotransferase (AST) ≥2.5× ULN, total bilirubin (TBL) ≥1.5× ULN, or alkaline phosphatase (ALP) ≥2× ULN at screening.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Apollo Multispeciality Hospitals limited

    Kolkata, 700054, India

  • Apollo Speciality Hospital - Teynampet

    Tamil Nadu, 600006, India

  • Aster CMI Hospital

    Bangalore, 560092, India

  • Christian Medical College Vellore

    Vellore, 632 004, India

  • Indraprastha Apollo Hospital

    New Delhi, 110076, India

  • Institute of Human Behaviour and Allied Sciences

    New Delhi, 110095, India

  • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute

    Mumbai, 400053, India

  • Manipal Hospital

    Bangalore, 560017, India

  • NIMHANS

    Bangalore, 560029, India

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