Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Cognitive Impairment or Mild Alzheimer's Disease

Exploratory PLatform Trial on Anti-Inflammatory Agents in Alzheimer's Disease (EXPLAIN-AD): A Randomized, Placebo-controlled, Multicenter Platform Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Various Anti-inflammatory Agents in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

ClinicalTrials.gov Identifier: NCT04795466

Novartis Reference Number: CADPT06A12201

Last Update: Nov 15, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this platform study is to evaluate the effect of anti-inflammatory agents on cognition in early Alzheimer's disease. Additionally, the safety and tolerability of these anti-inflammatory agents and the effects on central and peripheral inflammation will be evaluated.

Condition 
Mild Cognitive Impairment
Alzheimer Disease
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Oct 28, 2021
Completion date 
Feb 26, 2026
Gender 
All
Age(s)
45 Years - 90 Years (Adult, Older Adult)

Interventions

Biological
Canakinumab
Biological sub-cutaneous injection
Other
Placebo
Matching placebo subcutaneous injection

Eligibility Criteria

Inclusion Criteria:

Male or female, age ≥ 45 years and ≤ 90 years at the time of signing the informed consent;
Participant has a reliable study partner or caregiver can accompany the participant to all visits;
A diagnosis of probable MCI due to AD or mild AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria;
Confirmed amyloid and tau positivity via CSF sampling performed at screening;
Mini-Mental State Examination (MMSE) total score of 20 to 24 (inclusive) at screening; OR, MMSE total score of 25-30 (inclusive) plus a DSST score at least 0.5 standard deviation (SD) below normative data at screening.

Exclusion Criteria:

Use of an investigational agent or an approved product with the intent to modulate inflammation or modulate the course of AD (e.g., Tau ASOs, gene therapy, amyloid or tau vaccine):

Previous use of small molecules is allowed if discontinued for at least five half-lives, or at least 30 days from when the expected pharmacodynamic effect has returned to baseline prior to screening, whichever is longer
Previous use of monoclonal or polyclonal antibodies or other biologics is allowed if discontinued for at least five half-lives prior to screening
Current medical or neurological condition that might impact cognition or performance on cognitive assessments, e.g., MCI not due to AD, non-Alzheimer dementia, Huntington's disease, Parkinson's disease, stroke, schizophrenia, bipolar disorder, active major depression, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), active seizure disorder, or history of traumatic brain injury associated with loss of consciousness and ongoing residual transient or permanent neurological signs/symptoms including cognitive deficits, and/or associated with skull fracture;
If a historical MRI or CT scan has been performed, signs of major cerebrovascular disease shown on such scans (i.e., presence of infarction in greater than 25% of white matter; more than one lacune within basal ganglia or more than 2 lacunes in white matter);
Diagnosis of vascular dementia prior to screening (e.g.., modified Hachinski Ischaemic Scale score > 6 or those who meet the NINDS AIREN criteria for vascular dementia);

Study Locations

United States
Novartis Investigative Site
Recruiting
Charlestown, 02129
Massachusetts
United States
Novartis Investigative Site
Recruiting
Stony Brook, 11794-8161
New York
United States
Novartis Investigative Site
Recruiting
Knoxville, 37920
Tennessee
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Novartis Investigative Site
Recruiting
Fairfax, 22031
Virginia
United States
Finland
Novartis Investigative Site
Recruiting
Turku, 20520
-
Finland
Iceland
Novartis Investigative Site
Recruiting
Reykjavik, 101
-
Iceland
United Kingdom
Novartis Investigative Site
Recruiting
Plymouth, PL6 8BT
Devon
United Kingdom
Novartis Investigative Site
Recruiting
Guildford, GU27YD
Surrey
United Kingdom
Novartis Investigative Site
Recruiting
London, W1G 9JF
-
United Kingdom
Novartis Investigative Site
Recruiting
Motherwell, ML1 4UF
-
United Kingdom
Novartis Investigative Site
Recruiting
Southampton, SO30 3JB
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]