Start: August 27, 2018
End: August 15, 2021
What Is This Study About?
This Phase II study will assess the safety, tolerability, and effects of the investigational drug AMX0035 for people with late mild cognitive impairment or early dementia due to Alzheimer's disease.
Do I Qualify To Participate in This Study?
- Diagnosis of probable Alzheimer's disease or mild cognitive impairment due to Alzheimer's, based upon the National Institute on Aging-Alzheimer's Association criteria
- Montreal Cognitive Assessment of 8 to 26
- Able to read and write in English
- Geriatric Depression Scale of less than 7
- Not pregnant, lactating, or of child-bearing potential
- Study partner with at least 2 days per week contact with the participant and willing to accompany the participant to visits and complete partner study forms
- No known hypersensitivity to tauroursodeoxycholic acid or phenylbutyrate
- Biomarker (e.g., positron emission tomography scan, cerebrospinal fluid, volumetric magnetic resonance imaging [MRI] scan) indicative of Alzheimer's
- If taking cholinesterase inhibitor and/or memantine, on stable doses for 3 months prior to the study
Must NOT have:
- Any central nervous system disease other than suspected Alzheimer's, such as:
- Clinical stroke
- Brain tumor
- Normal pressure hydrocephalus
- Multiple sclerosis
- Significant head trauma with persistent neurological cognitive deficits or complaints
- Parkinson's disease
- Frontotemporal dementia
- Abnormal liver function, defined as aspartate aminotransferase (AST) test level and/or alanine aminotransferase (ALT) test level greater than 3 times the upper limit of normal
- Renal insufficiency as defined by a serum creatinine level greater than 1.5 times the upper limit of normal
- History of cholecystectomy or biliary disease
- Unstable medical condition (other than Alzheimer's disease) or significant illness
- Contraindication to MRI studies such as:
- History of a cardiac pacemaker or pacemaker wires
- Metallic particles in the body
- Vascular clips in the head
- Prosthetic heart valves
- Severe claustrophobia
- Past-year major active or chronic psychiatric illness such as:
- Bipolar disorder
- Obsessive compulsive disorder
- Significant neurodevelopmental disability
- Current thoughts of suicide or history of suicide attempt in past 5 years
- History of alcohol or other substance abuse or dependence in past 2 years
- Lab test abnormalities in B12, thyroid stimulating hormone (TSH), or other common lab tests that might contribute to cognitive dysfunction
- Current use of medications with psychoactive properties such as:
- Centrally acting antihistamines
- Sedative hypnotics
- Use of small-molecule investigational therapy for the treatment of Alzheimer's in past 3 months
- Use of any immunotherapy investigational therapy in past year
- Use of other investigational agents in past month
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Amylyx Pharmaceuticals Inc.
Alzheimer’s Drug Discovery Foundation
Source: ClinicalTrials.gov ID: NCT03533257