NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03752463
• Collaborator: Ministry of Science and Technology, Taiwan (Other)
• Enrollment: 154
• Location: 1
• Arms: 4
• Actual Duration (Months): 74.3
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: DAOI-A group; Drug: DAOI-B group; Drug: DAOI-C group; Drug: Placebo oral capsule	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: NMDA Enhancer for the Treatment of Mild Alzheimer's Disease
• Actual Study Start Date: May 22, 2015
• Actual Primary Completion Date: Jul 31, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAOI-A group	Drug: DAOI-A group; DAOI with A dose
Experimental: DAOI-B group	Drug: DAOI-B group; DAOI with B dose
Experimental: DAOI-C group	Drug: DAOI-C group; DAOI with C dose
Placebo Comparator: Placebo group	Drug: Placebo oral capsule; Placebo

Outcome Measures

Primary Outcome Measures

1. Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 [week 0, 8, 16, 24]

   Cognitive assessment

Secondary Outcome Measures

1. Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24 [week 8, 16, 24]

   Global assessment

2. Change from baseline in speed of processing (Category Fluency) at week 24 [week 0, 24]

   Cognitive assessment

3. Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24 [week 0, 24]

   Cognitive assessment

4. Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24 [week 0, 24]

   Cognitive assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of Alzheimer's disease

• MMSE between 10-26

• CDR 1

Exclusion Criteria:

• Hachinski Ischemic Score > 4

• Substance abuse/dependence

• Parkinson disease, epilepsy, dementia with psychotic features

• Major depressive disorder

• Major physical illnesses

• Severe visual or hearing impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	886

Sponsors and Collaborators

• Chang Gung Memorial Hospital
• Ministry of Science and Technology, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03752463
• Other Study ID Numbers: 105-3412C
• First Posted: Nov 26, 2018
• Last Update Posted: Aug 26, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Aug 26, 2021